26 May 2017 A two-year extension to the strategic agreement between Australia’s Generic and Biosimilar Medicines Association (GBMA) and the country’s government has been agreed as part of efforts to “further support a sustainable Pharmaceutical Benefits Scheme (PBS), as well as provide an extended period of certainty and predictability for the generic and biosimilar medicines sector”, following collaborative discussions through the Generic Medicines Working Group (GMWG). The deal builds on a five-year agreement struck in 2015 that was expected to generate total savings of A$6.6 billion (US$4.9 billion) over its full term, through mechanisms including price cuts and efforts to increase uptake in biosimilars (Generics bulletin, 5 June 2015, page 14). “Collaboration through the GMWG has led to the development of important measures to ensure a sustainable PBS, increase patient access to affordable medicines, and support the viability of the industry that supplies them,” said GBMA chair Allan Tillack. “GBMA supports measures to increase biosimilar uptake which are essential in the formation of a functioning and competitive biosimilars market, delivering PBS savings and increasing patient access.” The revised agreement also includes a ‘price disclosure moratorium’ that will increase the discounting threshold for drugs that have been in price disclosure for more than seven cycles from 10% to 30%, an investment in e-prescribing software that will support producing default prescriptions by international non-proprietary name (INN), and a commitment to continue to co-operate through the GMWG. Biosimilar discounts are to be raised. G Australia’s GBMA extends deal COMPANY NEWS 2 Hikma’s Advair blow leads it 2 to lower sales Acquisitions assist Piramal Pharma rise 2 Shanghai Pharma is weighing Stada offer 3 Teva will shut or sell its facility in Godollo 3 Granules India adds to 4 its APIs capacity Sawai misses target despite rising sales 5 Strides and Vivimed ink 5 pacts for two JVs Belupo out-of-stocks hit Podravka results 6 Nichi-Iko is short on sales despite Sagent 6 MARKET NEWS 7 Switch studies should allow 7 non-US reference Gottlieb talks pricing and FDA’s staff plans 9 UK pharmacy cut is upheld 10 by High Court USPTO is pondering patent review reforms10 PRODUCT NEWS 11 Two pay US$60.2mn to 11 settle K-Dur delay FKB’s adalimumab is accepted by the EMA 11 Cinfa makes progress with 12 EU pegfilgrastim Japanese players are planning NHI listings 13 USPTO knocks out a Humira 13 dosing patent FEATURES 14 France’s Biogaran backs 14 bold biosimilars strategy Building on its successful launch of biosimilar infliximab in France in 2015, Biogaran has set out its plans to launch rituximab later this year – as well as an overall strategy aimed at reinforcing its position in France’s biosimilars market – at an event in Paris. David Wallace was there. REGULARS Events – Our regular listing 6 Price Watch UK – Our regular listing 10 People – Sandoz has new heads 16 in Germany and UK Issue No.310 S anofi is celebrating the company’s “first major regulatory milestone for a biosimilar diabetes treatment” after the committee for human medicinal products (CHMP) within the European Medicines Agency (EMA) adopted a positive opinion recommending approval for the French firm’s biosimilar version of Eli Lilly’s Humalog (insulin lispro). The European Commission typically acts on such recommendations within 67 days. According to Sanofi, the CHMP’s recommendation for the firm’s SAR342434 biosimilar insulin lispro candidate – now called Insulin Lispro Sanofi – was based on a clinical development programme involving over 1,000 adults with type 1 or type 2 diabetes. The clinical package comprised a pharmacokinetic/pharmacodynamic Phase I study to evaluate the product’s similarity in exposure and activity compared to US and European Union (EU) insulin lispro 100 Units/mL, two multi-centre Phase IIIa clinical trials evaluating its safety and efficacy compared to US and EU insulin lispro 100 Units/mL in adults with type 1 or type 2 diabetes, and, finally, a safety study for insulin pumps in adults with type 1 diabetes. Sanofi’s recommendation comes just under three years after the firm’s own Lantus (insulin glargine) original became the reference brand for the first biosimilar insulin approved in Europe – Eli Lilly and Boehringer Ingelheim’s Abasaglar (Generics bulletin, 19 September 2014, page 1). Separately, Celltrion has received recommendations from the CHMP for three biosimilar rituximab candidates: Ritemvia; Tuxella; and Blitzima. Celltrion’s Truxima (rituximab) biosimilar rival to Genentech’s MabThera/Rituxan in late February became the world’s first biosimilar monoclonal antibody approved to treat cancers (Generics bulletin, 3 March 2017, page 1). All three biosimilars have been recommended for approval with indications to treat non-Hodgkin lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis, while Tuxella and Blitzima are also both recommended for the treatment of chronic lymphocytic leukaemia. Truxima was approved with all four indications, as well as rheumatoid arthritis. G Sanofi’s insulin lispro is endorsed by the EMA
Transcript
26 May 2017
Atwo-year extension to the strategic agreement between Australia’s Generic and BiosimilarMedicines Association (GBMA) and the country’s government has been agreed as part of
efforts to “further support a sustainable Pharmaceutical Benefits Scheme (PBS), as well asprovide an extended period of certainty and predictability for the generic and biosimilar medicinessector”, following collaborative discussions through the Generic Medicines Working Group(GMWG). The deal builds on a five-year agreement struck in 2015 that was expected to generatetotal savings of A$6.6 billion (US$4.9 billion) over its full term, through mechanisms includingprice cuts and efforts to increase uptake in biosimilars (Generics bulletin, 5 June 2015, page 14).
“Collaboration through the GMWG has led to the development of important measures toensure a sustainable PBS, increase patient access to affordable medicines, and support theviability of the industry that supplies them,” said GBMA chair Allan Tillack. “GBMA supportsmeasures to increase biosimilar uptake which are essential in the formation of a functioning andcompetitive biosimilars market, delivering PBS savings and increasing patient access.”
The revised agreement also includes a ‘price disclosure moratorium’ that will increase thediscounting threshold for drugs that have been in price disclosure for more than seven cyclesfrom 10% to 30%, an investment in e-prescribing software that will support producing defaultprescriptions by international non-proprietary name (INN), and a commitment to continue toco-operate through the GMWG. Biosimilar discounts are to be raised. G
Australia’s GBMA extends deal
COMPANY NEWS 2
Hikma’s Advair blow leads it 2to lower sales
Acquisitions assist Piramal Pharma rise 2Shanghai Pharma is weighing Stada offer 3Teva will shut or sell its facility in Godollo 3Granules India adds to 4its APIs capacity
Sawai misses target despite rising sales 5Strides and Vivimed ink 5pacts for two JVs
Belupo out-of-stocks hit Podravka results 6Nichi-Iko is short on sales despite Sagent 6
MARKET NEWS 7
Switch studies should allow 7non-US reference
Gottlieb talks pricing and FDA’s staff plans 9UK pharmacy cut is upheld 10by High Court
USPTO is pondering patent review reforms10
PRODUCT NEWS 11
Two pay US$60.2mn to 11settle K-Dur delay
FKB’s adalimumab is accepted by the EMA11Cinfa makes progress with 12EU pegfilgrastim
Japanese players are planning NHI listings13USPTO knocks out a Humira 13dosing patent
FEATURES 14
France’s Biogaran backs 14bold biosimilars strategyBuilding on its successful launch of biosimilarinfliximab in France in 2015, Biogaran has setout its plans to launch rituximab later this year –as well as an overall strategy aimed at reinforcingits position in France’s biosimilars market –at an event in Paris. David Wallace was there.
REGULARS
Events – Our regular listing 6Price Watch UK – Our regular listing 10People – Sandoz has new heads 16in Germany and UK
Issue No.310
Sanofi is celebrating the company’s “first major regulatory milestone for a biosimilardiabetes treatment” after the committee for human medicinal products (CHMP)
within the European Medicines Agency (EMA) adopted a positive opinion recommendingapproval for the French firm’s biosimilar version of Eli Lilly’s Humalog (insulin lispro).The European Commission typically acts on such recommendations within 67 days.
According to Sanofi, the CHMP’s recommendation for the firm’s SAR342434 biosimilarinsulin lispro candidate – now called Insulin Lispro Sanofi – was based on a clinical developmentprogramme involving over 1,000 adults with type 1 or type 2 diabetes.
The clinical package comprised a pharmacokinetic/pharmacodynamic Phase I study toevaluate the product’s similarity in exposure and activity compared to US and European Union(EU) insulin lispro 100 Units/mL, two multi-centre Phase IIIa clinical trials evaluating itssafety and efficacy compared to US and EU insulin lispro 100 Units/mL in adults with type 1or type 2 diabetes, and, finally, a safety study for insulin pumps in adults with type 1 diabetes.
Sanofi’s recommendation comes just under three years after the firm’s own Lantus (insulinglargine) original became the reference brand for the first biosimilar insulin approved in Europe –Eli Lilly and Boehringer Ingelheim’s Abasaglar (Generics bulletin, 19 September 2014, page 1).
Separately, Celltrion has received recommendations from the CHMP for three biosimilarrituximab candidates: Ritemvia; Tuxella; and Blitzima. Celltrion’s Truxima (rituximab) biosimilarrival to Genentech’s MabThera/Rituxan in late February became the world’s first biosimilarmonoclonal antibody approved to treat cancers (Generics bulletin, 3 March 2017, page 1).
All three biosimilars have been recommended for approval with indications to treatnon-Hodgkin lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis, whileTuxella and Blitzima are also both recommended for the treatment of chronic lymphocyticleukaemia. Truxima was approved with all four indications, as well as rheumatoid arthritis. G
Terms & Conditions: See www.generics-bulletin.com/subscribe.While due care has been taken to ensure the accuracy of information contained in this publication,the publisher makes no claim that it is free of error and disclaims any liability whatsoever for anydecisions or actions taken as a result of its contents.
Piramal Enterprises says it will “continue to seek opportunities inadding niche, differentiated capabilities that complement the
existing portfolio” of its Global Pharma unit, and will also explore“in-licensing opportunities for complex products” as it seeks to moveup the pharma value chain.
The Indian firm is looking to build on its recent acquisitions ofhigh-potency active pharmaceutical ingredient (API) specialist AshStevens (Generics bulletin, 26 August 2016, page 10), as well as itspurchase of hospital branded generics from both Janssen and Mallinckrodt
for upfront payments of US$155 million and US$171 million respectively(Generics bulletin, 14 October 2016, page 16; 3 February 2017, page 3).
Adding the high-margin hospital generics – the Dipidolor(piritramide), Hypnomidate (etomidate), Rapifen (alfentanil), Sublimaze(fentanyl) and Sufenta (sufentanil) anaesthetics and analgesics fromJanssen, as well as Gablofen (baclofen) and two analgesics underdevelopment from Mallinckrodt – helped to raise Global Pharma salesby 9.7% to Rs35.2 billion (US$548 million) in Piramal’s financialyear ended 31 March 2017 (see Figure 1). North America and Europeeach made up just over a third of Global Pharma sales.
Piramal – which is investing US$25 million to expand capacityat its Coldstream injectables plant in Lexington, US – said the GlobalPharma unit would during its current financial year add desflurane toits roster of inhaled anaesthetics. G
Figure 1: Breakdown by business segment of Piramal Enterprises’ sales in itsfinancial year ended 31 March 2017 (Source – Piramal)
Business Annual sales Change Proportionsegment (Rs millions*) (%) of total (%)
Failure to gain US Food and Drug Administration (FDA) approvalfor the first AB-rated substitutable generic version of
GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) andsubsequently achieve a previously anticipated launch in the secondhalf of this year will wipe up to US$130 million from Hikma’s full-year Generics sales in 2017, according to the Jordanian firm.
Having previously forecasted Generics turnover of US$800 million –of which the firm had said new launches, “primarily” generic Advair,were expected to contribute around 15%, or US$120 million – Hikmanow anticipates Generics sales of US$670 million this year in constantcurrency. “This assumes we do not launch our generic version ofAdvair in 2017,” Hikma commented, noting that it also reflected “theintensifying competitive environment in the US”.
Following Hikma’s 10 May FDA target action date for the firm’sVR315 fluticasone/salmeterol candidate, Hikma received a completeresponse letter informing the company that its abbreviated new drugapplication (ANDA) was not yet ready for approval (Generics bulletin,19 May 2017, page 1). Subsequently, the Jordanian firm said therewas “a low likelihood of approval this year” for the product.
Having also last year reported a US$14 million Genericsoperating loss owing to integration and impairment costs, Hikma noted:“Through our focus on portfolio optimisation and continued cost savings,we expect to achieve a slight improvement in the profitability of theGenerics business in 2017 after incurring additional operational costsrelated to our generic version of Advair.”
In total, Hikma believes its group turnover could fall by as muchas US$200 million, after forecasting total sales of US$2.0-2.1 billion,down from a previous forecast of US$2.2 billion. The firm continuesto anticipate global Injectables sales of US$800-US$825 million,observing: “New product launches, including the former Bedfordproducts, are enabling us to offset the impact of increased competitionon certain products.”
Meanwhile, Hikma’s Injectables operating margin – having satat 39.9% last year – is anticipated to be “in the high 30s, reflecting afurther step-up in research and development”. Hikma plans to publishhalf-year sales on 17 August.
Separately, Hikma has completed its move to a new London officeat 1 New Burlington Place in Mayfair, a change the firm said “createsthe capacity Hikma requires to deliver its strategic plans”. G
results Forecast
Hikma’s Advair blowleads it to lower sales
3GENERICS bulletin26 May 2017
company news
China’s Shanghai Pharmaceuticals has admitted an interest inacquiring Stada Arzneimittel, but has denied submitting an offer
for the German generics and OTC specialist.Responding to media reports that it had teamed up with private-
equity firm Advent to table a rival bid to the C66.00 (US$73.54) pershare offer by private-equity groups Cinven and Bain Capital that hasbeen backed by Stada’s executive and supervisory boards, ShanghaiPharma confirmed that it had “recently discussed about the possibilitiesof ‘Project Stada’ with a couple of financial investors”.
However, the Chinese company commented, there were “still alot of uncertainties” surrounding the potential collaboration. As ofissuing a statement on 17 May, Shanghai Pharma said it had notsubmitted any “official offer” for Stada. Furthermore, media rumoursthat it was prepared to offer C70 per share were “inconsistent with reality”.
Stressing that its own business operations were “in normalcondition”, Shanghai Pharma said any move for Stada would not requirea major restructuring, purchase or sale of assets that would have tobe submitted for shareholder approval.
Having obtained fairness opinions from three investment banks,Stada’s boards recently advised shareholders to accept the offer madeby Cinven and Bain’s Nidda Healthcare acquisition vehicle that valuesthe German group at around C5.32 billion, or 12.3-times earningsbefore interest, tax, depreciation and amortisation (EBITDA). Anacceptance period with a minimum threshold of 75% of shares endson 8 June (Generics bulletin, 19 May 2017, page 5). G
Mergers & acquisitions
Shanghai Pharma isweighing Stada offer
Teva plans to slash around 500 jobs at its deficient manufacturingfacility in Godollo, Hungary, “in the coming months” as part of
plans to either sell or close the site by the end of next year.Noting that sterile manufacturing at the facility – which is currently
subject to a US Food and Drug Administration (FDA) warning letter –would continue “at a reduced capacity” through to 30 June 2018, aTeva spokesperson told Generics bulletin: “After that date, the sitewill be sold or closed.”
“Because manufacturing levels at the plant will be reduced,approximately 500 jobs are at risk of elimination in the coming months,”the spokesperson continued. “Teva plans to initiate a search for asuitable buyer for the plant and is already in touch with relevantgovernment leaders and agencies, as well as securing assistance forour colleagues impacted by the reduction in employment levels.”
Opened nearly five years ago following a HUF22 billion (US$79.0million) investment, Teva’s 15,000 sq m Godollo site is capable ofproducing up to 200 million injectable units per year (Genericsbulletin, 2 November 2012, page 3).
Around a year ago, the FDA issued the facility with an importalert barring entry into the US products manufactured at the site, withthe exception of two products deemed in short supply (Genericsbulletin, 10 June 2016, page 5). Having voluntarily suspendedproduction at the facility in order to assess and remediate the agency’squality concerns, Teva was then served with a warning letter fordeficiencies including contaminated units and poor aseptic-processingtechniques (Generics bulletin, 4 November 2016, page 4).
According to a recent financial filing, property, plant andequipment balances at the site as of 31 March this year amounted toaround US$87 million, after Teva recorded an impairment chargeof US$80 million linked to the site in the fourth quarter of last year.
“Looking ahead, Teva will start consultation meetings with theorganisations that represent employees at the plant regarding the exactscope and timing of the planned downsizing and the best way to providesupport for affected colleagues, as required by law,” Teva revealed.“After consulting with our works council, Teva will also ensure thatemployees receive assistance in finding a new job and will provideoutplacement support and more for eligible colleagues.”
Teva pointed out the move was part of its ongoing “global networkoperations strategy”, which “is intended to align production capacitywith market and patient demand globally”.
In March, Teva said it was continuing to look for ways to reducecosts across the entirety of its business, including by streamliningactivities and functions throughout the business, but refused to commenton media reports that the firm was planning to cut around 6,000 jobsacross the globe over the next few years (Generics bulletin, 31 March2017, page 3). Having shut several facilities last year after acquiringActavis, Teva in 2017 and early 2018 plans to close facilities in Iceland,Malta, California and Singapore.
Meanwhile, Teva has reinforced its commitment to operating inHungary, stressing that its plants in Debrecen and Sajóbábony, as wellas its local commercial organisation – representing more than 2,000employees – were not included in the Godollo closure plans. “Teva willalso continue its ongoing investment in local production and researchand development activities in Debrecen,” noted the Israeli firm, whichclaims to have the largest and most comprehensive portfolio of drugsin the Hungarian market. Gn [email protected]
ManuFacturing
Teva will shut or sellits facility in Godollo
Dr Reddy’s Laboratories has chosen to use GE Healthcare’sFlexFactory single-use manufacturing platform to expand its
biologics facility in Hyderabad, India. The investment marks the firsttime that the technology will be installed in India.
In a joint statement, the two firms said the FlexFactory suite ofsingle-use technologies and associated process hardware would giveReddy’s a “more flexible and efficient” manufacturing set-up that wouldhelp the Indian company to compete in the global biosimilars arena.
“Dr Reddy’s will be able to increase its manufacturing capacityswiftly as the overall project set-up time for FlexFactory is typicallynine to 12 months,” the companies maintained, adding that the greatercapacity would support the Indian firm’s plans to bolster its existingbiosimilars portfolio through further launches.
and improve productivity by increasing the number of lots manufactured,as the change-over over time between products can be reduced by 50%or more,” the firms insisted. GE claims FlexFactory can reduce carbondioxide emissions by 75% and water and energy usage by around 80%.
Reddy’s currently markets follow-on biologics such as Grafeel(filgrastim), Reditux (rituximab) and Cresp (darbepoetin alfa) in Indiaand other developing markets. However, by early next decade the firmintends to launch its biologics “in developed markets”. Clinicalprogrammes to support filings in the US and Europe are underwayfor bevacizumab, pegfilgrastim, rituximab and trastuzumab. G
ManuFacturing
Reddy’s teams up with GE
4 GENERICS bulletin 26 May 2017
company news
Granules India is in the process of expanding its capacity to make itskey active pharmaceutical ingredients (APIs). Once its capacity
augmentation project at a complex in Bonthapally, India, is completed,the Indian firm says it will be able to produce 24,000 tons of paracetamolper year, 9,000 tons of metformin and 3,200 tons of guaifenesin.
As Figure 1 shows, paracetamol accounted for around a third ofGranules’ group turnover that increased by 4% to Rs14.4 billion(US$224 million) in its financial year ended 31 March 2017. Another30% of turnover came from metformin, 13% from ibuprofen, 5% fromguaifenesin and 3% from methocaramol.
The Indian group – which is also expanding its pharmaceuticalintermediates capacity in Gagillapur, India – said APIs and finished-dose formulations each represented 38% of its annual turnover, withthe remaining 24% coming from intermediates. On a regional basis,North America accounted for a little over two-fifths of group sales,Europe a quarter, India 18%, Latin America a tenth and the rest ofthe world 5%.
Targeting anDa filings in UsThrough a formulations facility that Granules acquired in Virginia,
US, the firm is aiming to “introduce value-added products” by filing5-6 abbreviated new drug applications (ANDAs) per year for USprescription and OTC generics facing “limited competition”. Duringits 2016-2017 financial year, Granules filed three ANDAs from asite in Gagillapur, India, and one from the Virginia facility in the US.
Furthermore, the group is building a greenfield facility in Vizag,India, to help it “venture into the oncology and speciality business”.
Reporting a 10% increase in group pre-tax profit to Rs2.05 billion,chairman and managing director Krishna Prasad Chigurupati pointed outthat the firm’s Granules Omnichem contract research and manufacturingservices (CRAMS) joint venture with Ajinomoto Omnichem hadposted a net profit of Rs249 million on a turnover of Rs2.00 billionin its first full year of operations. The venture, he added, had respondedto six observations made by the US Food and Drug Administration(FDA) following an audit of its Vizag facility.
Furthermore, the Indian firm’s Granules Biocause venture withChina’s Hubei Biocause – which manufactures ibuprofen API at a plantin Jingmen, China – increased its turnover by 29% to Rs2.20 billion. Gn [email protected]
Business strategy/annual results
Granules India addsto its APIs capacity
Paracetamol
MetforminIbuprofen
Others
Guaifenesin
Methocarbamol
Figure 1: Breakdown by product of Granules India’s turnover that increased by 4% toRs14.4 billion in its financial year ended 31 March 2017 (Source – Granules India)
TEVA UK has simplified its TevaOne generics purchasing schemefor community pharmacies and dispensing doctors. Changes madeas “a direct result of customer feedback” include: a lower net priceand higher, single monthly rebate; the introduction of a best ‘Tevanet price’ on over half of the TevaOne range; and dropping a yellowbonus products category. The membership scheme is availablethrough wholesalers AAH, Sangers/AAH, Alliance and Mawdsley’s.
BEXIMCO PHARMACEUTICALS increased its turnover by 12% toBDT3.81 billion (US$47.3 million) in the first quarter of this year. TheBangladeshi firm improved its pre-tax profit by 27% to BDT684 million.
INDOCO REMEDIES said it had received re-approval from theUK’s Medicines and Healthcare products Regulatory Agency(MHRA) for its Plant I solid-dose formulations facility in Goa, India.This followed an inspection conducted in December 2016. “The plantcontributes 40% of our International business,” the Indian firm noted.
JULPHAR saw its sales stall at AED369 million (US$100 million)in the first quarter of this year. That total included AED146 milliongenerated in Saudi Arabia and AED81.0 million in the group’sdomestic market of the United Arab Emirates (UAE). Julphar’sgross margin fell by almost four percentage points to 51.2%, whilehigher selling and distribution costs contributed to its operating profitsliding by 41% to AED48.4 million.
CAMBREX is investing US$2.4 million to increase its pilot-scaleactive pharmaceutical ingredient (API) capacity at its US facilityin High Point, North Carolina. The firm said adding a 37 sq m suitehousing two 2,000-litre reactors, as well as a filter dryer, wouldincrease the former PharmaCore site’s reactor capacity by around30%. Cambrex expects the suite to be “fully operational by 2018”.
SOPHARMA said it increased its turnover by 12% in the first quarterof this year, driven largely by a 24% increase in exports. TheBulgarian firm’s domestic sales rose by 4%. Highlighting an upturnin Russia amid a brightening economic outlook, chairman andexecutive director Ognian Donev said “our forecasts are that exportsales will grow over the next few months”. In Moldova, Sopharmarecently received local antitrust clearance to take a 51% controllingstake in RAP Pharma International, a wholesaler and distributorthat owns 10 pharmacies in Moldova and generated a turnover ofC3 million (US$3.4 million) last year.
SANECA PHARMA has obtained good manufacturing practice(GMP) clearance from Russia’s state institute of drugs to supplysolid, semi-solid and liquid dosage forms to Russia. The approvalcovers products such as film-coated tablets, hard and soft-gel capsules,ointments and topical liquids. Anthony Sheehan, chief executiveofficer of the Slovakian contract developer and manufacturer,identified Russia as “a key market” for Saneca’s growth plans.
AMRI said active pharmaceutical ingredient (API) turnover thatalmost doubled to US$106 million in the first quarter of this yearincluded US$43.4 million from its acquisition of Euticals’ bulk-drugbusiness (Generics bulletin, 29 July 2016, page 5). The US-basedgroup’s turnover rose by 55% to US$164 million, including US$23.4million from its Drug Product division and US$29.2 million fromits Discovery, Development and Analytical Services (DDS) unit.
SCINOPHARM TAIWAN posted an operating profit of TWD221million (US$7.37 million) on sales of TWD9.19 million in thefirst quarter of 2017. G
IN BRIEF
5GENERICS bulletin26 May 2017
company news
Strides Shasun will acquire 50% stakes in businesses operated byVivimed Labs in India and Singapore, as part of the firms’ strategies
“aimed at building product pipelines, scale and competitiveness” inthe US finished-dose formulation market.
In Strides and Vivimed’s domestic market, the Vivimed LifeSciences vehicle will own Vivimed’s US Food and Drug Administration(FDA) approved formulations facility in Alathur, Chennai. Sincebeing acquired by Vivimed from the former Actavis business four yearsago (Generics bulletin, 9 August 2013, page 8), the solid oral-dosefacility has passed two FDA inspections, and has also expanded itscapacity to 1.5 billion units per year.
Meanwhile, in Singapore, the Vivimed Global Generics operationwill house “certain intellectual-property rights” and approvedabbreviated new drug applications (ANDAs) belonging to Vivimed.
Strides – which has agreed to invest Rs660 million (US$10.2million) to set-up the former venture, and Rs90 million to establishthe latter – expects both transactions to close by 31 May, subject tocustomary closing conditions.
“Vivimed believes the joint venture partnership with Strides offersits portfolio of products the synergies from Strides’ existing front endin the US market,” Vivimed commented. “This, coupled with Vivimed’sproduct development pipeline for the US, offers the joint venture astrong opportunity to grow its footprint aggressively.”
Presenting its annual results for the year ended 31 March 2017,Strides – which earlier this year unveiled a major company shake-upto sharpen its focus on operating as a front-end, finished-doseformulations business (Generics bulletin, 10 February 2017, page 3) –said the ventures would “provide access to additional capacities” and a“strong product pipeline”, on top of ‘de-risking’ its manufacturing base.
The Indian firm’s sales climbed by 23% to Rs35.1 billion duringits 2017 financial year, driven by growth in the firm’s RegulatedMarkets business, including the US and Australia, as well as in Strides’Emerging Markets operation, partially offset by a sharp drop in activepharmaceutical ingredient (API) sales (see Figure 1).
Strides anticipates 15-20 product approvals in the US over the“next 12 months across various dosage formats”, after receiving fivefinal approvals and one tentative approval from the FDA during its2017 financial year. Meanwhile, Strides noted that it would imminentlyface an FDA inspection of its “flagship” facility in Bangalore,India, which “has a host of key products” pending FDA approval.
After upping its spending on research and development by four-fifths to Rs1.36 billion to support a raft of new product filings, Strides’earnings before interest, tax, depreciation and amortisation (EBITDA)rose by a third to Rs7.23 billion. Gn [email protected]
Figure 1: Breakdown by business segment of Strides Shaun’s sales in itsfinancial year ended 31 March 2017 (Source – Strides Shasun)
Annual sales Change Proportion(Rs millions) (%) of total (%)
Sawai Pharmaceutical’s sales advanced by 7.2% to ¥132 billion(US$1.18 billion) in the firm’s financial year ended 31 March
2017, just falling short of its ¥135 billion target. The Japanese company’soperating profit – which slipped by 11% to ¥20.6 billion due to “anincrease in the cost to sales ratio and increased research and developmentcosts” – fell more than a tenth shy of the firm’s estimated ¥23.5 billion.
Viewed by medical institution, Sawai noted that sales throughinsurance pharmacies had “maintained double-digit growth”. Overallpharmacy sales had lifted by a tenth, including rises in both drugstoreand dispensing pharmacy turnover, of 17.8% and 10.3% respectively.
Breaking down sales by distribution channels, Sawai observedthat turnover through wholesalers – which made up nearly three-fifthsof the total at ¥76.3 billion – had expanded, with a “nationwidedistribution network in the area of pharmacy and hospital markets”.Agency sales at ¥44.7 billion accounted for 37.3% of total turnover,with marketing alliance and other channels making up the remainder.
Sawai reported that overall sales volumes climbed by 14.3% dueto the “impact of generic drug promotion measures” by the Japaneseauthorities. Several of the firm’s drugs, when viewed by therapeuticcategory, achieved double-digit volume rises. This includedcardiovascular, central nervous system and blood/body fluidpharmaceutical products, which all “steadily increased”. In June, Sawaiplans to launch seven generics, including telmisartan, aripiprazoleand entecavir tablets (see page 13).
Outlining forecasts for its financial year ending 31 March 2018,Sawai expects sales to advance by 7.2% to ¥142 billion, while itsoperating profit is set to grow by 17.3% to ¥24.2 million. Research anddevelopment spending, however, is expected to drop by nearly a fifthfrom this year’s ¥10.2 billion to ¥8.30 billion. Sawai noted that theforecast “factored in various costs” of about ¥1.80 billion relating tothe firm’s planned US$1.05 billion acquisition of Upsher-Smith’sgenerics business, but no sales (Generics bulletin, 28 April 2017, page 3).
“Steady growth is anticipated to continue from an expectedincrease in net sales,” the Japanese company predicted, “due to factorssuch as patent expiration for many top-selling products.” G
annual results/results Forecast
Sawai misses targetdespite rising sales
Nippon Chemiphar believes it will bounce back from the almostflat sales year-on-year it has just published for its financial year
ended 31 March 2017, after forecasting sales growth of 6.5% to ¥38.0billion (US$343 million) in the Japanese firm’s current financial yearending March 2018.
Group turnover rose by 0.2% to ¥35.7 billion – or by ¥87 million –for the 12 months ended March 2017 although this was marginally abovethe firm’s ¥35.5 billion forecast, which had been revised in January.
Sales of the company’s proton-pump inhibitor lansoprazole climbingby 4.4% to ¥2.28 billion helped Chemiphar to increase its total Genericssales by 0.6% to ¥29.2 billion, compensating for lower sales of the firm’shighest-selling product amlodipine, as well as weaker sales of donepezil,rabeprazole, limaprost alfadex, pravastatin and voglibose.
Meanwhile, Chemiphar’s group operating profit slid by just undera tenth – or 9.8% – to ¥2.84 billion, following an increase in cost ofsales and research and development expenses. G
annual results/results Forecast
Chemiphar plots sales growth
6 GENERICS bulletin 26 May 2017
company news
Supply shortages for some drugs offered by its Belupo subsidiaryin Croatia contributed to Podravka’s Prescription sales dipping by
0.2% to CrK127 million (US$18.9 million) in the first quarter of thisyear. The Croatian group said lower sales in Croatia and Russia – thelatter suffering in comparison to a prior-year pick-up after implementinga new distribution agreement – were not fully compensated by strongersales in its Europe and New Markets regions.
A strong flu season in Croatia enabled Podravka to reportPharmaceuticals sales in its Adria region ahead by 1.1% to CrK143million (see Figure 1). For the same reason, the group’s total Non-Prescription turnover shot up by 31.2% to CrK28.2 million.
Pharmaceuticals sales in the group’s Europe region were boostedby growth in the Czech Republic, while a 81.4% turnover rise to CrK3.5million in its New Markets region reflected growth in Turkey.
Including sales through its own Deltis Pharm retail chain, theCroatian group achieved a 3.9% increase in total Pharmaceuticalsturnover to CrK190 million, aided by having introduced Vivaira(sildenafil) chewable tablets. However, most of the Pharmaceuticalsrise was due to a positive CrK5.4 million currency effect.
Podravka’s Pharmaceuticals business segment – which accountedfor just over a fifth of turnover for the food and beverages group –saw its gross margin fall by one percentage point to 50.2% as cost ofgoods rose by 6.1% due to taking on production staff in new facilities.And with operating expenses higher due to “stronger marketing activities”,the segment’s operating margin slid down by 2.7 points to 10.3%. G
Figure 1: Breakdown by region and product type of Podravka’s Pharmaceuticalssales in the first quarter of 2017 (Source – Podravka)
Region/ First-quarter sales Change Proportionproduct type (CrK millions) (%) of total (%)
Neuland Laboratories said its custom manufacturing solutions (CMS)and niche molecule business “continue to increase their contribution
to the overall business”, as the firm reported a 12% turnover rise toRs5.73 billion (US$88.3 million) in its financial year ended 31 March2017. Sucheth Davuluri, Neuland’s vice-chairman and chief executiveofficer, said the company “also made significant progress in bolsteringsystem integration and manufacturing infrastructure for the future”.
The Indian active pharmaceutical ingredients (APIs) producer alsoscaled up rotigotine and lacosamide, along with two new undisclosedCMS products. Lower finance costs helped to increase Neuland’s pre-taxprofit by nearly a fifth to Rs494 million. G
annual results
Neuland’s sales rise by a tenth
A¥12.1 billion (US$109 million) first-time contribution from itsSagent injectables business in North America could not prevent
Nichi-Iko Pharmaceutical from missing its turnover forecast in itsfinancial year ended 31 March 2017.
Due in part to its US$736 million takeover of Sagent completedin August last year (Generics bulletin, 22 July 2016, page 1), theJapanese group in November 2016 raised its full-year turnover forecastfrom ¥159 billion to ¥167 billion. But it more than halved its 12-monthoperating profit outlook from ¥14.2 billion to ¥6.60 billion, reflectingthe effects of acquisition-related expenses, reimbursement price cutsand higher biosimilar development costs.
Actual annual group turnover came in 13.8% higher at just over¥163 billion, missing the target by nearly ¥4 billion. Excluding Sagent’s
¥12.1 billion input, the Japanese group’s domestic sales rose by 5.4%,including generics turnover ahead by 7.8% to ¥135 billion that morethan offset a double-digit slide for ‘long-listed’ brands (see Figure 1).
Generics listed for National Health Insurance (NHI) reimbursementduring the firm’s 2016-2017 financial year contributed just ¥696 million.Sales of drugs listed in the 2015-2016 year rose by 39.4% to ¥10.4 billion.
Viewed by distribution channel, sales through wholesalers up by6.9% to ¥124 billion were the main driver of the turnover growth.
Nichi-Iko’s group gross margin of 34.7% was a little below the35.3% it had forecasted, while the company increased its research anddevelopment spending by 49.0% to ¥7.26 billion.
But an 18.6% rise in selling, general and administrative expensesto ¥48.2 billion was less than the firm had anticipated. This enabledNichi-Iko to far exceed its revised ¥6.60 billion operating profit forecastby posting a profit that was down by a third to ¥8.55 billion, including¥50 million from Sagent. Nevertheless, the group’s operating margintumbled by 3.8 percentage points to 5.2%. G
Figure 1: Breakdown by region of Nichi-Iko Pharmaceutical’s sales in its financialyear ended 31 March 2017 (Source – Nichi-Iko)
Region Annual sales Change Proportion(¥ millions) (%) of total (%)
Dishman Pharmaceuticals & Chemicals plans to increase itspenetration of the US market, leverage cross-selling opportunities,
and improve its capacity utilisation by focusing on “a large numberof small and mid-size companies”.
In its financial year ended 31 March 2017, the Indian contractresearch and manufacturing services (CRAMS) specialist increasedits turnover by 7.0% to Rs17.1 billion (US$265 million). G
Business strategy/annual results
Dishman targets US market
7GENERICS bulletin26 May 2017
markeT news
14-16 Junen 8th Biologics Formulation Development &
Drug Delivery ForumBerlin, GermanyKey topics at this three-day event will include the design ofbiological formulation, drug development, the stability process andthe regulatory environment.
Chicago, USATopics covered at this event will include regulatory science,translational medicine, patient engagement and value and access.
Contact: Drug information association. tel: +1 215 442 6162.e-mail: [email protected]. Website: www.diaglobal.org/Dia2017.
20-22 Junen CPhI China
Shanghai, ChinaOffering a wide range of conferences, networking opportunitiesand exhibitions, this event will also provide market updates andregulatory news.
12-13 septembern AAM Biosimilars Council Conference
Washington, USAThe key topics to be discussed at this two-day conference willinclude regulatory affairs, pricing and reimbursement and thepolicy environments surrounding access to biosimilars.
London, UKThis event will look at the commercialisation of biosimilars as well asregulatory guidelines, interchangeability, clinical trials and pricing.
Save the date ...n Global Generics & Biosimilars Awards 2017
24 October 2017, Frankfurt, Germany
14-16 Junen Joint Medicines for Europe and
IGBA Annual ConferenceLisbon, PortugalThis event will cover issues such as sustainability, biosimilars andemerging markets. There will be speakers from firmrms includingApotex, Medichem, Sandoz and Teva as well as representativesfrom the World Health Organization (WHO), the EuropeanMedicines Agency (EMA) and the European Commission.
Draft interchangeability guidance issued by the US Food and DrugAdministration (FDA) earlier this year must be amended to allow
biosimilar sponsors to use non-US-licensed reference products inswitching studies, bodies representing the biosimilars industry in boththe US and the European Union (EU) have urged.
Commenting on the draft guidance before the extended 19 Maydeadline (Generics bulletin, 31 March 2017, page 6), the US-basedBiosimilars Council and Biosimilars Forum, as well as Medicines forEurope’s Biosimilar Medicines Group, stressed the need to revise arequirement to use US-licensed reference products in switching studies(Generics bulletin, 20 January 2017, page 1). Otherwise, this wouldharm the streamlined, global development programmes that werecrucial to improving patient access to affordable biologics.
“The FDA’s concerns regarding subtle differences between US andnon-US versions of the reference product are scientifically unjustified,”argued the Biosimilars Council division of the US Association forAccessible Medicines (AAM). The Biosimilars Forum urged the agencyto clarify its expectations for scientific justification for using a non-UScomparator, while Europe’s Biosimilars Medicines Group insisted thatthe draft guideline “undermines the agreed and now well-establishedconcept of single or global development”.
Both US industry bodies opposed that draft guidance’s expectationof data to show interchangeability for all indications approved for thereference biologic. “The FDA does not have the authority to requiredata and information on indications and conditions of use for whichthe sponsor is not seeking approval,” the Biosimilars Council claimed.They also called for a clearer definition of “fingerprint-likecharacterisation”, urged flexibility on considering post-marketing dataand suggested that the FDA should permit primary endpoints for switchingstudies beyond pharmacokinetic (PK) and pharmacodynamic (PD)data, where more appropriate.
concerns over human factors studiesThe Biosimilars Council also voiced “fundamental concerns over
the proposed comparative-use human factors studies”.In a detailed response, Sandoz called on the FDA to clarify that
interchangeability did not “represent a higher standard for the productitself” and echoed several concerns outlined by the US industry groups.
Amgen – which holds FDA approval for biosimilar adalimumab,as well as for several reference biologics – maintained that “biosimilarapplicants should be required to seek licensure for all of the referenceproduct’s licensed indications in order to obtain an interchangeabilitydesignation”, provided such indications are not protected, as well as toprovide scientific evidence to support interchangeability for allindications, whether protected or not.
Furthermore, Amgen supported the draft guidance’s call fora US-licensed reference product in switching studies, arguing that“since the difference between two products is a factor that may triggeran immune response, testing with the actual product used in clinicalpractice in the US will be fundamental to answering the question ofthe risks associated with switching between the two products”.
By contrast, Pfizer – which also plays on both side of the biologicsindustry – said the need to use a US-authorised reference drug “hasthe potential to create practical challenges with regard to where thestudy can be conducted” and pointed out that “in many cases, supplychains are global”. Gn [email protected]
regulatory aFFairs
Switch studies shouldallow non-US reference
9GENERICS bulletin26 May 2017
markeT news
ABPI – the Association of the British Pharmaceutical Industry –insists “the practice of price hikes to generic medicines has hada damaging impact on trust of all pharmaceutical companies”. Theoriginators’ body issued its statement in response to the EuropeanCommission launching an investigation into Aspen Pharmacare’spricing practices for five mature oncology brands acquired fromGlaxoSmithKline (Generics bulletin, 19 May 2017, page 12). Aspen,it added, is not an ABPI member.
FEBELGEN – Belgium’s generics and biosimilars industryassociation – is one of eight bodies that have together formed theBelgian Medicines Verification Organisation (BeMVO) to overseethe local implementation of the European Union’s (EU) FalsifiedMedicines Directive. The originator and OTC industries are alsorepresented, as are pharmacists, wholesalers and parallel importers.FeBelGen’s director of public affairs, Pieter Boudrez, has assumedthe presidency of BeMVO, which has Jean-Pierre Engels as itsoperations director.
MORE THAN A THIRD of pharmaceutical manufacturers andcontract packagers are not currently preparing for global serialisationrequirements, despite impending deadlines, according to a surveyconducted by serialisation provider SEA Vision and its partnerZenith Technologies. Of those firms not currently preparing for thedemands of legislation such as the European Falsified MedicinesDirective and the US Drug Supply Chain Security Act (DSCSA),half said they lacked the necessary internal resources, while 15%believed it was too early to take steps.
AEMPS – Spain’s medicines and medical devices agency – hasintroduced measures to accelerate procedures for variations tomarketing authorisations. The agency said the widespread adoptionof electronic application forms had engendered changes in themarketing authorisation process. To speed up processes, AEMPSnow issues a decision on a variation before reviewing and amendingadministrative records in its RAEFAR database. Separately, AEMPSon 3 May hosted a seminar to explain extrapolation of indicationsfor biosimilars that included case studies for monoclonal antibodies.
THE EUROPEAN COMMISSION said 87% of more than 250responses to a public consultation agree that European Union (EU)co-operation on health technology assessment (HTA) shouldcontinue beyond 2020. Welcoming the outcome to the consultation,Health and Food Safety Commissioner Vytenis Andriukaitis saidhe was “keen to finalise a proposal on what form this co-operationwill take before the end of this year”.
IRELAND’S DEPARTMENT OF HEALTH has published a bookletarguing that Dublin would be “the ideal location for the EuropeanMedicines Agency (EMA),” once it leaves London as a consequenceof the UK’s ‘Brexit’ decision to leave the European Union (EU),which is expected in late March 2019.
BPI – the association of the German pharmaceutical industry – iscalling for “a fundamental reform of tender practices” to ensuresuch deals between manufacturers and health insurance funds do notendanger security of supply and competition in Germany. “The riskof supply shortages would be reduced if medicines tenders wereonly allowed when there were at least four competitors in the marketand also if the funds had to award contracts to at least three suppliers,of which at least one could demonstrate that it was producing withinthe European Union (EU),” argued the BPI’s deputy managingdirector, Norbert Gerbsch. G
IN BRIEF
Action must be taken by the US Food and Drug Administration (FDA)to ensure that the generic drug process “isn’t being inappropriately
gamed to delay competition and disadvantage customers”, the agency’sCommissioner of Food and Drugs, Scott Gottlieb, has insisted in hisfirst speech to staff at the FDA’s ‘All Hands’ meeting.
Gottlieb, who was recently confirmed as the FDA’s Commissionerof Food and Drugs by US Senators (Generics bulletin, 19 May 2017,page 16) after president Donald Trump nominated him for the positionin March (Generics bulletin, 17 March 2017, page 16), said he hopedto “have much more to say on this topic in the coming weeks”.
The Creating and Restoring Equal Access to Equivalent Samples(CREATES) Act, which prevents brand companies from blockingaccess to affordable generics by using safety programmes as a pretextto avoid providing samples, was recently introduced as draft legislationin the US House and Senate (Generics bulletin, 5 May 2017, page8), a decision that was welcomed by the Association for AccessibleMedicines (AAM) and its Biosimilars Council.
Meanwhile, Gottlieb commented, “too many consumers are pricedout of the medicines they need”. Despite acknowledging that the agencydoes not play a “direct role in drug pricing”, he asserted that the FDA“still needs to be taking meaningful steps to get more low-costalternatives to the market, to increase competition, and to give consumersmore options”. “This is especially true when it comes to complexdrugs and biosimilars,” he stressed.
Implementing the 21st Century Cures Act was a “key priority”,Gottlieb said, as well as tackling opioid abuse, which he described asthe agency’s “greatest immediate challenge”. Furthermore, Gottliebnoted that the agency had an “opportunity to greatly improve” throughits Office of Regulatory Affairs (ORA)’s ‘Program Alignment’, whichwas implemented on 15 May.
Aiming to “modernise and strengthen the FDA’s workforce”, theProgram Alignment plan organises both inspection and compliancestaff by FDA-regulated product, replacing a previous managementstructure based on geographic regions. This “major step”, the FDAinsisted, would “allow employees to become more specialised in theirwork where appropriate and modify certain processes with the goal ofimproved cross-agency communication, collaboration, and clarity inroles and responsibilities”.
“This is a significant change from ORA’s existing geographic-based model, where employees, regardless of their area of expertise,may do work in more than one programme area,” the FDA said. G
regulatory aFFairs
Gottlieb talks pricingand FDA’s staff plans
French generics industry association Gemme has urged newly-electedFrench President Emmanuel Macron to “respond to the numerous
challenges” facing the country’s healthcare system.Emphasising that France lags behind other countries when it comes
to the uptake of generics, Gemme said it would look forward to workingwith Macron’s new government on a “coherent and ambitious” healthcarestrategy that was based on access to healthcare for all. Improved useof generics and biosimilars could save as much as C7.5 billion (US$8.4billion) over Macron’s five-year Presidential term, without sacrificingquality of care, Gemme suggested. G
regulatory aFFairs
France’s Gemme asks Macron
10 GENERICS bulletin 26 May 2017
markeT news
Up to the minute live retail market pricing is availablefor the UK and Eire on Wavedata Live at wavedata.net.Alternatively, contact Charles Joynson at WaveData Limited, UK.Tel: +44 (0)1702 425125. E-mail: [email protected].
Sumatriptan surges in MaySumatriptan 50mg tablets in packs of six saw their average UK
trade price rocket up by almost seven times in the first threeweeks of May, according to the latest figures provided by WaveData.
Comparing UK trade prices between the periods 1-30 April2017 and 1-22 May 2017, the average price grew by 588% to £8.28(US$10.74) from £1.20 in April – based on averages calculatedfrom at least 53 data points – as the lowest available price jumpedby almost half from £0.58 to £0.85 per pack. The Department ofHealth (DoH) has offered a concession price of £28.65.
Meanwhile, betahistine tablets in three presentations saw theiraverage prices more than double. Despite a lowest offer thatremained unchanged at £0.65, 120-tablet packs of 8mg tablets sawan average increase of 130% to £3.03. And 84-count packs of thesame strength saw an average jump of 154% to £2.51. The DoHhas offered pharmacists a £6.33 concession for the smaller pack.
For betahistine 16mg tablets in 84-count packs, the rise waseven more pronounced, with an average price that more than trebledto £4.60, representing a rise of 251%. A concession of £12.55has been offered by the DoH.
Venlafaxine extended-release capsules saw the biggest averageprice drops during the first three weeks of May, with 28-count packsof 150mg capsules falling by 70% to £3.28 and the same pack sizeof the 75mg strength dropping by 67% to £2.07. G
PRICE WATCH ....... UK
Multiple petitions against a single patent, patent-claim amendments,claim-construction standards and extending the duration of
proceedings are among the issues being considered by the US Patentand Trademark Office (USPTO) as it evaluates patent proceedingsconducted by its Patent Trial and Appeal Board (PTAB) followingthe introduction of the America Invents Act (AIA).
“Our top priority today is to make sure the PTAB’s AIA proceedingsare as effective and fair as possible, within our Congressional mandate,”USPTO director Michelle Lee stated. “Now is the right time to examineand make any needed reforms to these proceedings, because we havefive years of data and experience to guide us,” she maintained.
Examining data spanning September 2012 to March 2017, Leesaid two-thirds of patent-review petitions were instituted, while anotherthird were settled, so only a third ever reached a final written decision.Of the completed reviews, 66%, or 1,014 cases, found all patent claimsat issue to be unpatentable, while 17% invalidated some claims, andanother 17% upheld all claims.
An analysis of 204 pharma inter partes reviews filed by genericsfirms that was recently conducted by law firm Foley & Lardnerfound that 75% of petitions were instituted by the PTAB.
Of 41 cases that had reached a written decision, 59% found allpatent claims to be unpatentable, while 39% upheld all claims. Mylanled the way in terms of petitions. G
intellectual ProPerty
USPTO is ponderingpatent review reforms
Reducing the regulatory burden on generic drugs covered by a patentis among the aims of a major pricing reform that Health Canada
has opened for consultation until 28 June. Other proposed amendmentsto Canada’s Patented Medicines Regulations include expanding thebasket of reference countries for setting prices of patented drugs, usingbroader factors such as pharmacoeconomics to determine whetherprices are excessive, and requiring patentees to report all third-partyrebates and similar discounts.
For generics approved as abbreviated new drug submissions(ANDS), Health Canada proposes removing the requirement forpatentees to systematically report pricing information to the country’sPatented Medicines Prices Review Board (PMPRB). Rather, amendedregulations would require pricing information only in the event of acomplaint or at the request of the PMPRB.
Increased focus on high-risk drugs“This proposal would be consistent with an increased PMPRB
focus on drugs that are at greatest risk of excessive pricing due to thedegree of market power held by the patentee,” Health Canada explained.
Discussing proposals to remove Switzerland and the US fromCanada’s basket of seven reference-price countries – and to replacethem with Australia, Belgium, Japan, the Netherlands, Norway, SouthKorea and Spain – Health Canada notes that when the regulationswere first conceived 30 years ago, “policy-makers believed that patentprotection and price were key drivers of pharmaceutical research anddevelopment investment”. However, it had since become clear thatthere was “no evidence of a determinant link between domestic pricesand the location of industry research and development investment”. G
Pricing & reiMBurseMent
Canada consults over pricing
Plans made by the UK government to cut funding for communitypharmacists were not unlawful, High Court Justice Andrew Collins
has ruled in a joint judicial review initiated by the UK’s PharmaceuticalServices Negotiating Committee (PSNC) and National PharmacyAssociation (NPA). “I have, with some regret, concluded that I cannotproperly quash the decision,” Collins stated.
In October, the PSNC criticised the UK Department of Health’sproposed pharmacy package for 2016/17 that would cut funding to£2.687 billion (US$3.49 billion) and reduce it further to £2.592 billionin 2017-18 (Generics bulletin, 21 October 2016, page 10). The PSNCthen applied to the UK’s High Court for a judicial review, contendingthat the UK’s health secretary, Jeremy Hunt, “failed to carry out alawful consultation” on the proposals (Generics bulletin, 9 December2016, page 6). The NPA also applied for a review shortly after (Genericsbulletin, 27 January 2017, page 8).
“Cuts of the nature required will inevitably produce somehardships for individual pharmacies,” Collins acknowledged. “Butthat cannot mean that in times of need for some retrenchment, no cutscan be made.” Claiming that the Department of Health had “givendetailed and careful consideration to the way in which the cuts canbe made”, Collins did however state that “different means might havebeen better”. Yet, he noted, “it is only if unreasonableness is establishedthat is it proper to intervene.” G
retailing
UK pharmacy cut isupheld by High Court
11GENERICS bulletin26 May 2017
proDUcT news
Racecadotril 10, 30 mgTaste Masked Granules in SachetBioequivalent to Tiorfan® Bioprojet France
Drug Delivery Solutions Pvt Ltd
Athena has an EU GMP approved facility forGranules, Tablets, Capsules & Sachet lines.
After “more than 17 years of litigation and four rounds of mediation”,Merck & Co and Upsher-Smith Laboratories have reached a
proposed settle agreement with direct purchasers of Merck’s K-Dur(potassium chloride) to dismiss litigation alleging that the firms“unlawfully delayed” the availability of generic versions of thehypokalaemia treatment through a ‘reverse payment’ scheme.
According to a motion filed by direct purchaser plaintiffs in aNew Jersey district court requesting that the court enter the proposedsettlement order, Merck and Upsher-Smith have agreed to pay US$60.2million in cash to resolve allegations of anticompetitive conduct. Thefirms deny allegations of unlawful conduct and any wrongdoing.
“Preliminary approval of the settlement is appropriate,” directpurchasers argued in support of the proposed settlement. “Thesettlement assures that all class members will receive a substantialcash settlement payment, and that the litigation will finally be put torest, avoiding continuing litigation and potential appeals.”
According to the initial complaint filed in April 2001, Merck’sSchering-Plough business in June 1997 agreed to settle abbreviatednew drug application (ANDA) litigation with Upsher-Smith, providingthe generics firm with US$60 million in exchange for Upsher-Smithdelaying market entry for generic K-Dur until September 2001.
However, the complaint alleged, Upsher-Smith had been preparedto launch commercially “no later than May 1998”. G
HyPokalaeMia treatMents/litigation
Two pay US$60.2mnto settle K-Dur delay
Fujifilm Kyowa Kirin Biologics (FKB) – the Japan-based jointventure of Fujifilm and Kyowa Hakko Kirin – has had its marketing
authorisation application for the firm’s proposed biosimilar version ofAbbVie’s Humira (adalimumab) accepted for review by the EuropeanMedicines Agency (EMA).
Having in December 2014 initiated a Phase III global clinicalstudy of the firm’s FKB327 adalimumab candidate at “sites in theUS, Europe and other countries” to compare the efficacy and safetyprofile of FKB327 with Humira in patients with moderate to severerheumatoid arthritis, FKB in October last year published top-line resultsshowing that the biosimilar met the primary endpoint and “prespecifiedcriteria for equivalence, and there were no significant differences inthe rate of adverse events between FKB327 and Humira” (Genericsbulletin, 28 October 2016, page 13).
Based on these results, FKB revealed, the firm had decided to file themarketing authorisation application for FKB327 to the EMA last month.
“We are delighted that the EMA has accepted the application,”commented Hideaki Nomura, president chief executive officer of theFKB venture. “The acceptance of this filing brings us one step closer tomeeting the demand for high-quality and affordable biopharmaceuticals.”
In a bid to clear a path in the UK to launch the biosimilar, FKB in2015 began patent revocation proceedings targeting dosing regimenpatents belonging to AbbVie. Two months ago, the UK’s High Courtreached a favourable verdict for the Japanese firm, ruling that FKB –alongside Samsung Bioepis – was entitled to a declaration that AbbVie’spatented 40mg once every two weeks dosage regimen for Humira wasobvious in light of prior art as of patent priority dates (Genericsbulletin, 10 March 2017, page 15).
In addition to its adalimumab candidate, FKB is also conductinga Phase III “international joint clinical trial” for a biosimilar versionof Genentech’s Avastin (bevacizumab) – under the banner FKB238 –through its Centus Biotherapeutics alliance with AstraZeneca. G
Biological Drugs
FKB’s adalimumab isaccepted by the EMA
AUS Court of Appeals has upheld a preliminary injunction awardedto Mylan and Apicore by a US district court that prevents Aurobindo
from marketing its proposed generic isosulfan blue 1% injectable. Butit pared down the scope of the injunction from three to one US patentsafter deciding that the lower court had erred in reaching a conclusionof infringement relating to two US process patents.
The panel of three appeals court judges found that a Texasdistrict court in February this year did not err in finding that Aurobindo“did not raise a substantial question as to [the] validity” of US puritypatent 9,353,050, and therefore an injunction was justified.
Concerning US process patents 7,622,992 and 8,969,616, however,the appeals court decided that there remained a “substantial questionconcerning infringement”, and thus the granting of a preliminaryinjunction “constituted an abuse of discretion”.
“We conclude that the district court’s analysis of equivalence inthis case was flawed, no doubt because of the sparse and confusingcase law concerning equivalents, particularly the paucity of chemicalequivalence case law and the difficulty of applying the legal conceptsto the facts,” the appeals court commented in modifying the injunction. G
oncology Drugs
US court modifies injunction
12 GENERICS bulletin 26 May 2017
proDUcT news
FRESENIUS KABI has introduced a “first-to-market generic” rivalto Genzyme’s Clolar (clofarabine) paediatric leukaemia treatmentin the US. The launch follows approval of clofarabine 20mg/20mlsingle-use vials for Kabi’s privately-owned development partner,Abon, which said Clolar generated US sales of US$67 million lastyear. Clofarabine marks Abon’s first approval of an abbreviated newdrug application (ANDA). Litigation between Abon and Genzyme overthe only patent listed against Clolar in the Orange Book maintainedby the US Food and Drug Administration (FDA) – US patent5,661,136 that expires on 14 July 2018, including a six-monthpaediatric extension – was dismissed by a New Jersey district court.
EMA – the European Medicines Agency – is recommending changesto prescribing information for vancomycin antibiotics “to ensureappropriate use in the treatment of serious infections caused bygram-positive bacteria”. The agency’s committee for human medicinalproducts (CHMP) concluded that vancomycin should not be used totreat staphylococcal enterocolitis or for clearing the gut of bacteriain patients with weakened immune defences. Furthermore, the CHMPproposed to the European Commission, the starting dose forvancomycin by infusion should be calculated according to the ageand the weight of the patient.
HIKMA has launched in the US ethacrynic acid 25mg tablets thatare equivalent to Aton Pharma’s Edecrin oedema treatment.Edenbridge holds the only other US generic approval for the diuretic,which Hikma said generated US sales of around US$55 million inthe 12 months ended March 2017.
TEVA has added to its US generics portfolio with the launch of ageneric version of Santarus’ Glumetza (metformin) 500mg and1,000mg extended-release tablets. Lupin and Sun Pharma holdsimilar approvals for the diabetes treatment.
BIOCAD says it has won its first tender in Syria. The Russianfirm will supply trastuzumab to the country’s ministry of health.
LANNETT has obtained approval from the US Food and DrugAdministration (FDA) for levocetirizine dihydrochloride 2.5mg/5mloral solution, a rival to UCB’s Xyzal paediatric treatment for allergicrhinitis. The US generics specialist will make the solution at theCarmel, New York, facility of its Silarx subsidiary.
SEVERAL INDIAN COMPANIES have been accused by the country’sNational Pharmaceutical Pricing Authority (NPPA) of offeringcombination drugs without applying for prior price approval. TheNPPA has demanded the companies produce production and salesdetails by 15 June.
PHARMADAX has introduced generic Seroquel XR (quetiapinefumarate) 50mg, 150mg, 200mg, 300mg and 400mg extended-release tablets in the US through its marketing partner, TruPharma.The antidepressant and schizophrenia treatment marks the firstcontrolled-release product, and the second overall, approved forthe Taiwanese company.
CELLTRION has filed two petitions for inter partes review ofGenentech’s US patent 6,407,213 that is entitled ‘Method for makinghumanized antibodies’. The Korean biosimilars developer cites abroad array of prior art that it insists renders anticipated or obviousseveral of the ‘213 patent’s claims. The petitions – which includeCelltrion’s partner, Teva, as an interested party – state that the Koreanfirm is not aware of any litigation related to the ‘213 patent. G
IN BRIEF
Cinfa Biotech – the biosimilars arm of Spain’s Infarco – is preparingto submit its biosimilar pegfilgrastim for approval in the European
Union (EU) this year after announcing positive top-line data from asecond clinical trial comparing the drug to Amgen’s Neulasta brand.
The firm’s B12019 pegfilgrastim candidate met all primary andsecondary endpoints of the trial, which compared pharmacodynamicsand immunogenicity to Neulasta. The safety of Cinfa’s proposedpegfilgrastim was also deemed “comparable” to the brand. The multiple-dose, randomised, double-blind cross-over study enrolled 96 healthyvolunteers in Germany and was designed “based on scientific advicefrom the European Medicines Agency (EMA)”.
After Cinfa last year unveiled positive data for its biosimilarpegfilgrastim from a previous clinical study, the company announcedit was seeking partnerships to market the chemotherapy-inducedneutropenia treatment in Europe (Generics bulletin, 8 July 2016,page 11). Shortly after, the Spanish firm revealed it had initiated asecond study for B12019 (Generics bulletin, 7 October 2016, page 8).
Noting that B12019 now had a “comprehensive data package”,Cinfa’s managing director, Ruediger Jankowsky, said that “both studies,together with the analytical and functional comparability data, supportthe high quality of our product candidate”. G
Biological Drugs
Cinfa makes progresswith EU pegfilgrastim
Valeant has received a boost in its attempts to fend off US competitionto the firm’s Xifaxan (rifaximin) gastrointestinal brand after it
reached an agreement with abbreviated new drug application (ANDA)filer Actavis, at the Teva operation’s request, to stay litigation andextend the 30-month stay on US Food and Drug Administration (FDA)approval. The agency recently issued draft bioequivalence guidance.
“The parties agree and the court ordered that Actavis’ 30-monthregulatory stay shall be extended from 12 August 2018 until no earlierthan 12 February 2019, and could be longer if the litigation stay lastsfor more than six months,” revealed the Canadian firm, which suedActavis in March last year. “Legal action is stayed through 30 April2018 and cannot be lifted prior to 31 October 2017. All currentlyscheduled litigation activities, including the January 2018 trial date,have been indefinitely removed from the court docket.” G
gastrointestinal Drugs
Actavis stays on US rifaximin
Dr Reddy’s is set to “launch soon” a generic version of Janssen’sDoxil (doxorubicin) liposome injection in the US after obtaining
approval from the US Food and Drug Administration (FDA) for thefirm’s first complex depot injectable. The Indian firm said that theapproval was “an outcome of extensive collaboration” with its partner,Natco, on “research and development and manufacturing capabilities”.
The doxorubicin liposome 2mg/ml dispersion for intravenous use isavailable in 10ml or 30ml glass, single-dose vials. Citing QuintilesIMSdata, Reddy’s observed that US sales of the Doxil brand and Sun Pharma’sgeneric were US$196 million in the 12 months ended March 2017. G
oncology Drugs
Reddy’s ready for Doxil rival
13GENERICS bulletin26 May 2017
proDUcT news
Coherus BioSciences’ chief Denny Lanfear has lauded the “valueof the inter partes review (IPR) process” after the US Patent and
Trademark Office’s (USPTO’s) Patent Trial and Appeal Board (PTAB)invalidated all claims within a US dosing regimen patent shieldingAbbVie’s Humira (adalimumab) following a successful IPR petitionlaunched by the biosimilars developer.
AbbVie’s US patent 8,889,135 claims a method for treatingrheumatoid arthritis by administering 40mg of Humira subcutaneouslyevery 13 to 15 days, according to Coherus, which is developing anadalimumab biosimilar under the banner CHS-1420.
“We believe this successful outcome validates Coherus’ leadershipin biosimilar intellectual property and the effectiveness of our platform,”Lanfear commented. “This case unmistakably demonstrates the valueof the IPR process and the need to preserve the IPR process to enablereview of patents that may inappropriately extend market exclusivityand prevent needed competition.”
Presenting its financial results for the first quarter of this year,Coherus said it anticipated submitting a 351(k) biologics licenseapplication (BLA) for CHS-1420 “at or near the end of the secondquarter of 2017”, and moreover was continuing to “advance intellectualproperty strategies” supporting a potential launch in 2018.
Following the PTAB’s decision on the ‘135 patent, Coherus cannow press on with plans to initiate in the second half of this year apharmacokinetic study with a formulation “not impacted” by AbbVie’sUS patent 9,114,166, which covers an isotonic formulation ofadalimumab. The USPTO last year denied AbbVie’s petition to conductan IPR of the patent (Generics bulletin, 11 November 2016, page 13).
Meanwhile, in the third quarter of this year, Coherus anticipatesreceiving a decision on four petitions for IPR concerning AbbVie’sUS patent 9,085,619 – which covers formulations of adalimumab thatdo not contain a buffer – filed at the beginning of this year (Genericsbulletin, 3 February 2017, page 10).
Having in 2017 presented both positive top-line 24-week treatmentresults for CHS-1420 in patients with psoriasis and bioequivalencedata in a pharmacokinetic study comparing the biosimilar and Humira,Coherus recently revealed that partnering discussions for the firm’santi-tumour necrosis factor (anti-TNF) franchise – including the firm’sCHS-0214 etanercept candidate – were “underway”, targetingagreements in the first half of this year.
Coherus’ sales dropped by US$12.2 million to US$0.16 million inthe first quarter of this year, following the termination of a developmentand commercialisation agreement with Shire covering CHS-0214(Generics bulletin, 7 October 2016, page 9). G
Biological Drugs
USPTO knocks out aHumira dosing patent
Celltrion plans to file a US application for its Herzuma (trastuzumab)biosimilar rival to Genentech’s Herceptin by the end of June. The
South Korean company said that Herzuma – along with the Truxima(rituximab) biosimilar version of the originator’s Rituxan/MabTherathat Celltrion filed with the US Food and Drug Administration (FDA)in April – would be marketed in the US by Teva under the terms ofthe pair’s collaboration deal struck late last year (Generics bulletin,14 October 2016, page 1). G
Biological Drugs
Celltrion eyes US trastuzumab
Three of Japan’s leading domestic generics companies are anticipatingNational Health Insurance (NHI) listings for alternatives to several
major drugs during June.Nichi-Iko, Sawai and Towa are each expecting listings for generic
rivals to Boehringer Ingelheim’s Micardis (telmisartan) 20mg, 40mgand 80mg tablets. Nichi-Iko and Sawai are also set to obtain listingsfor the Micamlo (telmisartan/amlodipine) and Micombi (telmisartan/hydrochlorothiazide) combination tablets, while Towa is targetingtelmisartan orally-disintegrating tablets.
Earlier this year, Daiichi Sankyo Espha announced clearance tomake and market authorised generics of the Micardis, Micamlo andMicombi brands that are distributed in Japan by Astellas for BoehringerIngelheim. The Japanese firm said it would apply for NHI listings forthese, along with authorised generics of Olmetec OD (olmesartan)orally-dispersible tablets and Crestor (rosuvastatin) tablets, “as soonas a stable supply can be secured”.
montelukast and aripiprazole listingsNichi-Iko and Sawai are each set to list rivals to Singulair/Kipres
(montelukast) in delivery forms including granules and chewabletablets, while both generics firms will join Towa in securing listingsfor alternatives to Abilify (aripiprazole) in various forms.
Sawai and Towa are also targeting Sanwa’s Seibule (miglitol)orodispersible tablets for treating diabetes, while Sawai is also anticipatinga listing for generic Baraclude (entecavir) in the same format. Nichi-Iko islining up listings for generic Evista (raloxifene) and Livalo (pitavastatin).G
antiHyPertensives/resPiratory Drugs
Japanese players areplanning NHI listings
Samsung Bioepis has been sued by Janssen in a New Jersey districtcourt over three US patents protecting Remicade (infliximab). The
suit covers US cell-growth media patents 7,598,083 and 6,900,056that expire on 7 February 2027 and 5 October 2022 respectively, aswell as US purification patent 6,773,600 that expires on 4 June 2023.
In the suit, Janssen also alleges that, in obtaining US approval forits Renflexis (infliximab-abda) biosimilar in April this year, the jointventure between Samsung and Biogen “short-circuited” the statutory‘patent dance’ dispute-resolution procedure. G
Biological Drugs
Bioepis faces infliximab suit
New Zealand’s Pharmaceutical Management Agency (Pharmac) isinviting by 6 July offers to supply oral pregabalin and/or gabapentin.
While gabapentin has been listed on the country’s pharmaceuticalschedule since April 2001 – currently as 100mg, 300mg and 400mgcapsules in the form of the Neurontin original, Teva’s Arrow-Gabapentinand Mylan’s Nupentin – pregabalin is not funded for use throughcommunity pharmacies or hospitals. Pointing out that any changes tothe pharmaceutical schedule are unlikely before November this year,Pharmac observes that several New Zealand patents “may be relevantto some pregabalin synthetic methods and formulations”. G
ePilePsy Drugs
Pharmac ponders pregabalin
BUsIness sTraTeGy
14 GENERICS bulletin 26 May 2017
Since it was founded in 1996, Biogaran – asubsidiary of France’s Servier – has focused ongeneric medicines, becoming over the past 20 years
the country’s leading domestic player in the Frenchgenerics market, according to March 2017 data fromlocal market researcher GERS.
Offering a portfolio of more than 800 presentationsand a network of 29 French manufacturing sites, Biogaranboasts that 55% of its products are manufactureddomestically, and 93% within Europe. Moreover, morethan three-quarters of French patients – 77% – arefamiliar with the Biogaran name, according to the firm.
The firm has broken new ground with small-molecule launches such as its recent introduction ofFrance’s first and only current generic rival to Crestor(rosuvastatin calcium), sold by Biogaran as a rosuvastatinzinc form that is listed against the brand in the country’srépertoire of substitutable generic equivalents (Genericsbulletin, 21 April 2017, page 1).
But in 2014, the firm took the strategic decision tocomplement its small-molecule generics business byinvesting in biosimilars. The initiative first bore fruit inearly 2015 with the launch of Remsima (infliximab),the first biosimilar monoclonal antibody (mAb), througha marketing tie-up with South Korean developer Celltrion(Generics bulletin, 27 March 2015, page 17).
And as Biogaran looks ahead to its expected launchin France of its second biosimilar – Celltrion’s Truxima(rituximab) – in September this year, the Frenchfirm’s president, Pascal Brière, has set out the firm’slarger strategy for biosimilars at an event in Paris.
Billing Biogaran as a “pioneer of complexbiosimilars in France”, Brière pointed out that the firmhad become the second biggest supplier of biosimilarsto France’s hospital market following the launch ofinfliximab, according to GERS data (see Figure 1).
Hospira – which also markets the Inflectra versionof infliximab – remains the largest player in France’sC112 million (US$126 million) hospital biosimilarsmarket, more than doubling its sales in the 12 monthsto March 2017 by adding C46.0 million. But after more
than trebling its sales compared to the previous 12-monthperiod, Biogaran comfortably took second position,overtaking Sandoz which slipped slightly to C10.3 millionand Teva which dropped by a tenth to C2.8 million.
The remainder was composed of players withannual sales of under C1 million, such as Eli Lilly withC470,000, Arrow with C149,000, and Biogen and GedeonRichter each with sales under C10,000.
Brière acknowledged that there was further roomfor growth in bringing biosimilar infliximab to thehospital market, observing that total biosimilar infliximabsales – also including Hospira’s Inflectra – hadexperienced “encouraging but modest” growth sinceBiogaran launched Remsima.
Citing GERS figures from February 2015 to March2017, Brière noted that biosimilar infliximab hadachieved average volume penetration of 25.5% over the12 months to March 2017, with the figure reachingmore than a third in the final month (see Figure 2).
But there were still plenty of potential savings tounlock, he declared. If all prescriptions for brandedinfliximab were switched to biosimilars, he claimed, afurther C95 million in savings could be generatedannually, on top of the C35 million already generatedby biosimilar infliximab in the year to March 2017.
Xavier Carruel, head of Biogaran’s biosimilarsbusiness unit, concurred with Brière, admitting that“volume and speed of penetration for biosimilars are stilltoo weak”. It was essential, Carruel said, to “create acontext favourable to biosimilars”. This could beachieved through several means, which required theinvolvement of all healthcare professionals.
Educating and informing was a key part ofencouraging greater biosimilar uptake, Carruel said,pointing to “significant” needs for information fromboth healthcare professionals and patients. Sharingpositive clinical experiences – such as switch studies,
France’s Biogaran backsbold biosimilars strategyBuilding on its
successful launch of
biosimilar infliximab
in France in 2015,
Biogaran has set out its
plans to launch
rituximab later this
year – as well as an
overall strategy aimed
at reinforcing its position
in France’s biosimilars
market – at an event in
Paris. David Wallace
was there.
BiogaranC22.9m, +209%
HospiraC76.6m, +150.8%
Others
TevaC2.8m, -10.2%
SandozC10.3m, -3.1%
Figure 1: Breakdown by sales value of France’s C112 millionhospital biosimilars market for the 12 months ended March2017 (Source – Biogaran/GERS)
0
10
20
30
40
50
1 2 3 4 5
Vol
ume
(%)
50
40
30
20
10
0
Feb 15
Apr15
Jun15
Aug15
Oct15
Dec15
Feb 16
Apr16
Jun16
Aug16
Oct16
Dec16
Feb 17
0.1% 1.1%4.2%
4.5%8.2%
11.2%17.4%
16.7%21.4% 22.2%
25.1%27.1%
31.3%
Figure 2: Volume penetration by infliximab biosimilars of France’s hospital infliximab marketbetween February 2015 and March 2017 (Source – Biogaran/GERS)
Mar17
34.9%
15GENERICS bulletin
BUsIness sTraTeGy
26 May 2017
complementary Phase III trials and observational studies –was also a key way of creating this favourable context.
Also important was the clarification of rulessurrounding interchangeability, he observed, especiallywhen it came to the role of healthcare authorities.
“More and more European health authorities andacademic bodies are in favour of interchangeability,”Carruel outlined, pointing to endorsements fromorganisations in Finland, Germany, Ireland and theNetherlands, as well as recent statements from bodiessuch as the European Crohn’s and Colitis Organisation,ECCO (Generics bulletin, 6 January 2017, page 15)and the British Oncology Pharmacy Association, BOPA(Generics bulletin, 31 March 2017, page 9).
Local medicines agency ANSM had also recentlychanged its position on interchangeability, publishingan information paper in mid-2016 that indicated thatbiosimilars may be able to be substituted for their brandedcounterparts under certain conditions (Generics bulletin,13 May 2016, page 1). The move was welcomed byFrench generics industry association Gemme.
Regulators in the US were also in the midst ofdeveloping a guideline on interchangeability, Carruelpointed out (see page 7), while key information onswitching between Remicade (infliximab) and itsbiosimilars had been offered by the Norwegian NOR-Switch study published last year (Generics bulletin,28 October 2016, page 12).
Another motivating factor for biosimilars wouldbe the way that the “efficiency of the hospital model”would lead to “significant savings on biological drugs”.This would be in part due to the mandatory price cutsthat were implemented by France’s economic committeefor healthcare products (CEPS), such as a 10% cut tothe brand price upon biosimilar market entry, followedby a 12% cut a year after biosimilar launch.
Capitalising on the opportunity provided bybiosimilars would require a “modern, proactive” approach,insisted Brière, stating that Biogaran was adopting “anambitious and innovative” position that would “combineeconomic efficiency with safe and secure healthcare”.
Addressing the received belief that biosimilarscould not be treated in the same way as small-moleculegenerics, Brière said that this was true only to an extent.In terms of the regulatory approach, the complexityof biosimilars required chemical and structural studiesthat were different to small-molecule generics.
But in terms of prescribing and delivering biosimilars,Brière maintained that it was “false” to state that genericsand biosimilars could not be treated in the same manner.While the European approach to biosimilars left decisionson interchangeability, switching and substitution tonational authorities, this was a purely “political decision”.
In particular, he believed, “interchangeability isrecognised by the European Medicines Agency (EMA)”.There was “no difference in efficacy and no differencein tolerance” between biosimilars and brands.
Brière emphasised that the ‘Biosimilars in theEuropean Union (EU)’ information guide recentlypublished by the EMA and European Commission(Generics bulletin, 12 May 2017, page 1) provided astrong foundation for Biogaran’s approach.
Most significantly, Brière pointed out, the documentexplained that “over the last 10 years, the EU monitoringsystem for safety concerns has not identified any relevantdifference in the nature, severity or frequency of adverse
effects between biosimilars and their reference medicines”.As part of Biogaran’s “unique response to the
issues surrounding biosimilars”, Brière said, the firmwould help offer information on biosimilars and theirrelated regulatory processes by participating in workshopsand events involving patient associations.
To reassure healthcare professionals on the efficacyand tolerance of biosimilars, the firm would offer detailsof two Biogaran observational studies, as well as a stabilitystudy, along with “complementary clinical data” andswitch studies such as NOR-Switch.
Service-based elements to accompany Biogaran’sbiosimilars included a rapid-dosing kit for infliximab,while the firm would seek to “explain the texts andpositions of ANSM”, as well as distributing therecommendations of academic bodies, to “clarify theirpositions” on biosimilars.
technology” for manufacturers and suppliers, Brière said,with research and development costs of C30-C120 millionper molecule, a period of seven or eight years neededfor development, and a 50%-75% probability of success.Moreover, manufacturing required an investment ofaround C150-250 million per site.
There was also a pronounced difference betweenbiosimilar penetration in the community pharmacy andhospital markets, with community pharmacy-orientedmolecules – such as insulin – experiencing only weakpenetration and modest growth (see Figure 3).
Nevertheless, Brière maintained that the potentialfor savings from biosimilars was significant. He cited aQuintilesIMS study that predicted around C9 billionsavings would be generated in France up to 2020, equatingto around C3 billion of potential savings per year(Generics bulletin, 8 April 2016, page 14).
Truxima’s launch in 2017 would offer “a strongsavings potential for hospitals” of around C67 million,according to Biogaran’s figures, assuming a biosimilarprice 25% lower than the originator.
And as well as Remsima and Truxima, Carruelacknowledged, Biogaran was looking ahead to othermolecules. He revealed that the firm was in “advanceddiscussions” with Celltrion over a further collaborationon the South Korean firm’s Herzuma (rituximab)biosimilar, which was approved by the EMA earlier thisyear (Generics bulletin, 3 March 2017, page 1). G
6Insulin glargine
Etanercept
Infliximab
Somatropin
Filgrastim
Epoetin alfa
Reference biologic brand Biosimilar
99.2%
99.8%
78.8%
55.5%
12.8%
82.0%
0.8%
0.2%
21.2%
44.5%
87.2%
18.0%
Figure 3: Breakdown by volume of the shares of France’s total biologics market enjoyed by Frenchbiosimilars for six molecules as of December 2016 (Source – Biogaran/Gemme/GERS)
“Biogaran is adopting an
ambitious and innovative
position on biosimilars
that combines economic
efficiency with safe and
secure healthcare”
16 GENERICS bulletin 26 May 2017
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Strides Shasun says it is “reconstituting” its board to “guide themanagement team in rolling out future strategies”. The firm
announced that it had already completed “several organic and inorganicstrategies to put in place pivots for growth”, after recently unveilinga broad restructuring initiative to focus on operating as a front-end,finished-dose formulations business (Generics bulletin, 10 February2017, page 3).
kumar becomes chairmanFounder and executive vice-chairman Arun Kumar would move
to a non-executive position as chairman of the board, Strides revealed,adding that he would “continue to provide strategic inputs tomanagement”. Meanwhile, Homi Rustam Khusrokhan – who overthe last five decades has held senior positions in companies includingGlaxoSmithKline (GSK), Tata Group and ICICI Bank – is set tojoin the board as an independent director.
Strides’ group chief executive officer, Shashank Sinha, andgroup chief financial officer Badree Komandur will become executivedirectors of the board. “After long and distinguished association withthe company,” Strides concluded, “MR Umarji, PM Thampi, AKNair and Abhaya Kumar will relinquish their board positions.”
The moves come as Strides has just set out plans for two jointventures with Vivimed in India and Singapore (see page 5). G
resHuFFles
Strides shakes up itsmanagement board
Sandoz has promoted Tim de Gavre to become country head ofits UK operation, replacing Stephan Eder, who has moved to
become the Novartis subsidiary’s country head in Germany.De Gavre – who has served as the chair of the British Biosimilars
Association (BBA) within the British Generic Manufacturers Association(BGMA) since April 2016 (Generics bulletin, 22 April 2016, page 8) –was previously head of Sandoz UK’s Specialty unit. He took up theSpecialty position in 2014, having served for the previous two yearsas global brand director for Sandoz’ Omnitrope (somatropin) biosimilar.
Eder had been Sandoz’ country head in the UK and Ireland sincelate 2013, before which he spent three years as leader of the OTCbusiness unit within Sandoz Russia. G
aPPointMents
Sandoz has new headsin Germany and UK
CLARIS LIFESCIENCES has appointed Shyamsunder Sharmaas an executive director to oversee the Indian firm’s human resourcesand corporate communications functions. At the same time, non-executive director Chetan Majmudar has resigned.
EAGLE PHARMACEUTICALS has named Pete Meyers as its chieffinancial officer. Meyers – who most recently served as chieffinancial officer of Motif BioSciences – will also serve as Eagle’sprincipal financial officer and principal accounting officer. The firmnoted that David Riggs, who has been Eagle’s chief financial officersince 2013, would have “continued engagement with the company”.
INTEC PHARMA has announced that its chief executive officer anddirector Zeev Weiss has resigned from both positions to “pursueother professional opportunities”. Weiss said he would “remainactively involved” as the firm’s clinical and business developmentconsultant. The drug-delivery specialist’s board of directors hasappointed Giora Carni as interim chief executive officer while itsearches for Weiss’ replacement. Carni has been a company directorsince 2006 and was Intec’s chief executive officer from 2006 to 2014.
VALEANT has announced appointments to its dermatology leadershipteam: Michael McMyne as vice-president of sales, and StaceyWilliams as vice-president of marketing. Lainie Keller has joinedin the newly-created role of vice-president of corporatecommunications. McMyne and Williams both join Valeant fromMerz’ North American business, the former as vice-president ofoperations and the latter as senior marketing director. Keller joinsValeant from Merck & Co, where she most recently served asdirector of corporate media relations.
PERRIGO has appointed Rolf Classon and Adriana Karaboutisas independent directors of its board, following a recommendationby one of its largest shareholders, Starboard Value. Upon thisrecommendation, the US firm also agreed that Ellen Hoffing resignfrom the board. In February, Perrigo overhauled its board after firstreaching an agreement with Starboard, which included plans forHoffing to step down (Generics bulletin, 17 February 2017, page 16).
PARABOLIC DRUGS has revealed that Ashok Kumar Jindal willjoin the Indian firm as chief financial officer. G
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