BIOSIMILARS - Regulation and Market Trends

1

BIOSIMILARS --------------------

Regulation, Market Trends AND

Originators strategyJoseph PategouInternational Strategy and [email protected]

23/05/2016 Regulatory issues on the development of Biosimilars – Joseph Pategou 2

SUMMARY

Executive Summary

Introduction

I. Methodology

II. Global economic situation

III. Regulation and market trends of Biosimilars

IV. Strategic positioning for Originators

Conclusion

Information about the author

Appendix

23/05/2016 3

EXECUTIVE SUMMARY: 7 Key Points

Regulatory issues on the development of Biosimilars – Joseph Pategou

Reduction of health spending in OECD countries

Clear difference between Biosimilars and Generics

EU: the most advanced market for Biosimilars

Substitution and interchangeability are great issues for all actors

Germany: the most favorable regulation for Biosimilars

Regulation issues on Biosimilars evolve quickly

10 levers of Originators to face Biosimilars

23/05/2016 4

INTRODUCTION


23/05/2016 5

Introduction to Biosimilars

A Biosimilar is a biological medicine that is similar to, but not identical to, another biological medicine that has already been approved

Due to its complex molecular structure and unique manufacturing

process, a Biosimilar is not a copy of its originator biologics

Concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004

EU is the first region in the world to have set up a legal framework and a regulatory pathway for Biosimilars

EU regulatory framework inspired many countries(Australia, Canada, Japan, USA)


Source: Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC

Which regulatory framework for Biosimilars in Europe?

23/05/2016 6

Research Question


What strategic positioning for the Originator manufacturers?

23/05/2016 7

METHODOLOGY


23/05/2016 8

METHODOLOGY: 3 Steps

Scope of the study: France, United Kingdom, Germany and Italy

1. Identify difference between Generics and Biosimilars

Secondary data

2. Identify the position of main actors

22 interviews

4 types of organizations

10 questions

6 topics

3. Benchmarking

13 companies

Example: Amgen

From 2000 to 2015


Sample of the interviews

Sample of the Interviews.pptx

23/05/2016 9

Source: Interview Bx: Biosimilars Unions


Sample of the Interviews

Types of Organizations Numbers

Unions 6 (Bx: 4)

Learned Societies 7

Patient Associations 3

Authorities 4

Others 2

LIEN HYPERTEXTE

23/05/2016 10

GLOBAL ECONOMIC SITUATION


23/05/2016 11

ECONOMIC SITUATION: Reduction of health spending

The total spending of health is declining since 2009 in OECD countries

The most affected by the economic crisis are the main concerned for the Panorama health 2013 of the OECD

In this context, countries must make their health systems more:

Productive Efficient Affordable

Countries reduce spending:

Lower prices of medical goods Budgetary restrictions Wage cuts in the hospital sector

Example of France and Germany

12% 11%


Source: OECD

23/05/2016 12

REGULATION


Naming

Interchangeability

Substitution

SmPC

Extrapolation

Marketing Authorization

WHO

National Authorities

EMA

DECISION MAKER6 KEY TOPICS

Suggestion of the World Health Organization:

4-letter code at the end of every drug name

Draft form (not implemented)

Link to manufacturer and manufacturing site of the active substance

All biologicals with INNs

Example: “epoetin lambda bcde”

Position of the interviewees on Naming

Difference of position:

Right approach: BQ allows identification and traceability

Wrong approach: BQ gives the perception of important differences between Biosimilar

and Originator

23/05/2016 13

Naming

DECISION MAKER

WHO

BQ: Biological Qualifier


Source: WHO

100% 100%

50%50%

100%

0%

20%

40%

60%

80%

100%

Authorities PatientAssociations

Learned Societies Unions

Right approach

Wrong approach

23/05/2016 14

SmPC

European Medicines Agency

The SmPC of the Biosimilar product need to be consistent

with the SmPC of the reference product

The SmPC must include the notion of Biosimilar and

a reference to the EMA website for further information

Position of the interviewees on SmPC


Identical SmPC: No clinical differences between the Biosimilar and Originator

Different SmPC : Will be of help and allow comparison

DECISION MAKER

EMA


Source: EMA

100%

33% 20%

80%67%

80%

20%0%

20%

40%

60%

80%

100%



Identical SmPC

Different SmPC

Substitution is the pratice of dispensing one medicine instead of another equivalent

and interchangeable medicine at the pharmacy level without consulting the prescriber

23/05/2016 15

Substitution

DECISION MAKER

National authorities

Country Substitution

United Kingdom Not authorized

France Decree Pending

Italy Not authorized

Germany Possible between Biosimilars 11%

89%

0%

20%

40%

60%

80%

100%

4MM

Substitution

No substitution

Position of the interviewees on

Substitution


No substitution: The decision to treat a patient with a Biosimilar should be taken by a

qualified healthcare professional and the patient

4 MM: Masse Markets : Italy, UK, Germany and France

Position of each country on

Substitution


Source: See appendix

23/05/2016 16

Interchangeability

DECISION MAKER

National authorities Interchangeability: an important topic

Interchangeability is the medical practice of changing one medicine for another that is

expected to achieve the same clinical setting and in any patient on the initiative, or with

the agreement of the prescriber

Germany has accepted the principle of interchangeability, for the Paul-Ehrlich-Institute

“Biosimilar medicines can be prescribed to patients, who previously have not received

any treatment with biologics, as well as those patients who have previously received the

original molecule”

In the United Kingdom, interchangeability is permitted for Biosimilars and rests with the

responsible clinician in consultation with the patient

In France, interchangeability is permitted for Biosimilars and rests with the responsible

clinician in consultation with the patient (patient consent and clinical monitoring)

Absence of interchangeability in Italy

This situation will evolve due to the international context (scientific data available and

other countries)


Source: FDA

European Medicines Agency

Extrapolation is the scientific concept of granting a clinical indication to a medicine

without requiring new clinical efficacy and safety data to support an indication

If Biosimilarity has been demonstrated in one indication, extrapolation to other

indications of the reference product could be acceptable with appropriate scientific

justification ( eg: clinical experience)


Extrapolation: Biosimilars comparability has been demonstrated in one indication

No extrapolation: Biosimilars are not identical to the Originators

23/05/2016 17

ExtrapolationDECISION MAKER

EMA

Position of the interviewees on Extrapolation


Source: EMA

100%

65% 60%

100%

35%20%

0%

20%

40%

60%

80%

100%



Extrapolation

No extrapolation

Comparison of the MA between Originators, Generics, and Biosimilars

Comparative studies in terms of :

Quality

Safety

Efficacy

Aim to demonstrate that these three parameters are similar to the Originator

23/05/2016 18

Marketing Authorization

File of the demand of MA Originators Generics Biosimilars

Module 1Administrative Information

Yes Yes Yes

Module 2Summary of Module 3, 4

and 5Yes Yes Yes

Module 3Quality (manufacturing

process)Yes Yes Comparative studies

Module 4Safety (non-clinical studies)

Yes Not required Comparative studies

Module 5Efficacy (clinical studies )

Yes Bioequivalence Study Comparative studies

DECISION MAKER

EMA


Source: EMA

23/05/2016 19

Key Learnings

KEY POINTS DIFFERENCE IDENTICAL

Naming x

SmPC x

Substitution x

Marketing authorization x

Interchangeability x

The most favorable countries in terms of regulation


Germany 6 KEY TOPICS

United

Kingdom6 KEY TOPICS

France 6 KEY TOPICS

Italy 6 KEY TOPICS

Comparison between Biosimilars and Generics

Favorable

Less favorable

Germany has the most favorable regulation for biosimilars

One commun point between Biosimilars and Generics regulation

23/05/2016 20

MARKET TRENDS


23/05/2016 21

Global Picture

Global market:

2,6 billion$ in 2015

25 billion$ in 2020

Due to a new market

Biosimilars sales by Region

First Biosimilar medicine approved by European Commission


Source: IMS and EGA

Focus on EU :

Most advanced market

11% of total biologics sales in 2011

50% of the off-patent biological market in 2020

20 Biosimilars (7 actives substances) in 2015

Biosimilars market in volume and value in 2011

New market.pptx

Total Biosimilar Sales by Region (2013-2023).pptx

23/05/2016 22

Source: IMS


Anti-TNF, Insulins and Onco MABs are the key biologics

LIEN HYPERTEXTE

23/05/2016 23Regulatory issues on the development of Biosimilars – Joseph Pategou

Source: BioTrends Research Group A: Actual ; F: Forecast

$ billion

USA

EU

Japan

Biosimilars Sales by Region

LIEN HYPERTEXTE

23/05/2016 24

Main Actors


Source: IMS and EGA

4 Categories of Players

Top 3 Innovator Companies affected by Biosimilars

4 Categories of Players.pptx

Top 3 innovator companies affected by Biosimilars.pptx


4 Categories of Players

LIEN HYPERTEXTE


Source: IMS and EGA

Amgen

AbbVie

Roche

Top 3 innovator companies affected by Biosimilars

Innovator companies affected by Biosimilars

LIEN HYPERTEXTE

23/05/2016 27

Evolution of Biosimilar and Originator manufacturing cost

-8%-10%

-15%

-16%

-13%

-10%

-7%

-4%

-1%

Y 0 Y 2 Y 5

-25% -30%

-50%

-55%

-35%

-15%

Y 0 Y 2 Y 5

0

Evolution of retail price for Originators

Evolution of hospital price for Biosimilars

Before the arrival of a Biosimilar on the market, we observe a price cut of 10% and 15%

Example: APHP bought Inflectra after the company offered a discount of 45 percent

Our interviewees vision on the evolution of price


Source: APHP, Reuters

Outside the Scope

Outside the Scope.pptx


Source: Bloomberg & IMS

Outside the Scope

RemicadeBiosimilars

Countries CompaniesName of the

drugDiscount

Market Share in 2015

Norway Orion Pharma Remsima 72% 70%

PolandHospira

Orion Pharma

Inflectra

Remsima51% - 69% 67%*

*Market share of Inflectra and Remsima in Poland

What strategies for these companies?

Cost Strategy• Looking for Experience Effect (loi de Wright)• Looking for more Market Share

User Experience Strategy• Identify the Value Creation of the drug• Have more Clinical Data on the drug

Open the doors to Interchangeability and Subtitution

LIEN HYPERTEXTE

23/05/2016 29

Leadership Position of Originators

The interviewees think that the market share of Originators will depend on 4 factors:

4 Factors

Regulation

Trust

Cost

Adaptability


Source: Interview

23/05/2016 30

Choosing between biosimilars of the same reference product

The interviewees think that 3 factors influence the choice of a biosimilar:

3 Factors

Clinical trial data

PriceManufacturer

site


Source: Interview

1

3 2

23/05/2016 31

Biosimilars and Generics: Nature, Regulation and Market trends

Comparison between Biosimilars and Generics in terms of Nature, Regulation and Market

trend, the position of the interviewees:


Not comparable: The biosimilars differ in the complexity of the manufacturing process,

large complex molecules and the inherent variability in the biological systems used

Comparable: The common point between biosimilars and generics is only the drop in

drug prices and loss of patents


Source: Interview

20%40%

100% 100%80%

60%

0

0,2

0,4

0,6

0,8

1



Comparable

Not comparable

23/05/2016 32

STRATEGIC POSITIONING FOR ORIGINATORS


23/05/2016 33

Sample of the Benchmarking

Benchmarking

13 companies

From 2000 to 2015

Identify the strategic positioning of Originator manufacturers

Face Biosimilars competition

Company Product

Glaxosmithkline Augmentin, Paxil, Amoxicilline

Lilly Prozac

Sanofi Cardizem

Servier Périndopril

Merck & Co Claritin

Fournier Lipanthyl

Astrazeneca Oméprazole Astrazeneca

Merck-Lipha Glucophage

MSD Inegy , Zocor

Pfizer Gabapentine pfizer

Amgen Neupogen

Bristoll Myers Squibb Buspar

Teva Simvastatine Teva


Price

Patent

Legal Action

Cooperation

Product

Prescription

Market Saturation

New Market

EnvironmentalStrategy

Brand Strategy

23/05/2016 34

The 10 levers of Originators to face Biosimilars

10 Levers

1

4

3

2

8

7

6

5

10

9


23/05/2016 35

Focus on Environmental Strategy

Environmental Strategy

3 Actions:

Promote the obligation of the four-letter code (BQ) at the end of the name of Biosimilars

Promote for the Biosimilar a different Summary of Product Characteristics (SmPC) from the Generics and Originators

Promote the substitution of Biosimilars by physicians

All this will contribute to highlight that biosimilars unlike generics are not

identical to originators, but different products

9

BQ: Biological Qualifier


Source: Interview

Brand Strategy

2 Actions:

Create more adhesion of patients and healthcare professionals to their drugs (adhesion to the brand)

Bring more services to patients and healthcare professionals on their drugs (For example monitoring)

Example: Amgen’s Evaluation of personalized patient counseling for Enbrel

Phase IV trial with 300 patients with RA Patient adherence and persistence to therapy in chronic disease

Justify a premium price for Enbrel over Biosimilars

10

23/05/2016 36

Focus on Brand Strategy


Source: InterviewRA: Rheumatoid Arthritis

23/05/2016 37

Key Learning


Source: Interview

No Single but Combination of Strategy

No Global but Glocal Strategy

Example: Neupogen, Amgen

The case of Neupogen.pptx


Source: Interview

Localization

NeupogenAmgen

Global USA Mature Market Emerging Market

Patent Legal Action• Cooperation • New Product

• Market Saturation

New Market

Combination and Glocal Strategy

4 Locations for 6 Strategies

LIEN HYPERTEXTE

23/05/2016 39

CONCLUSION


23/05/2016 40

Conclusion


Reduction of health spending in OECD countries

Clear difference between Biosimilars and Generics

EU: the most advanced market for Biosimilars

Substitution and interchangeability are great issues for all actors

Germany: the most favorable regulation for Biosimilars

Regulation issues on Biosimilars evolve quickly

10 levers of Originators to face Biosimilars

23/05/2016 41

Information about the author


I am fascinated by healthcare and the experience of many

companies to develop new types of drug with the aim of saving

lives around the world.

Main topics of passion in the healthcare:

- Strategy

- Digital

- Innovation

- Biosimilars

If you want to know more, please contact me:

[email protected]

M. Joseph Pategou

23/05/2016 42

THANK YOU FOR YOUR ATTENTION


23/05/2016 43

APPENDIX


23/05/2016 44

THE 10 LEVERS: Comparison of levers used to face Biosimilars and Generics

Levers Biosimilars Generics

Price X X

Patent X X

Legal Action X X

Cooperation X X

Product X X

Prescription - X

Market Saturation - X

New Market X -

Common points between strategy to face the Biosimilars and Generics competition


23/05/2016 45

Price


1

866,08 € 858,47 € 858,47 €

749,01 € 746,17 €

691,91 € 688,28 € 703,74 € 700,89 €

0

300

600

900

2006 2008 2009 2012 2015

Pric

e (

eu

ro)

NEUPOGEN 48 MU (0,96 MG/ML)

TEVAGRASTIM 48 MUI/0,8 ML

Graph 23: The evolution of Neupogen and Tevagrastim price over 2006-2015

23/05/2016 46

Cooperation


4

The company’s CEO Kevin Sharer stated in January 2011 that in order to drive

growth, the company was going to consider entering the biosimilars sector but “in a

controlled way,” (Beasley, 2011).

In December 2011, Amgen announced it had signed a deal with Watson to develop

and commercialize a number of oncology biosimilar monoclonal antibodies (MAbs).

Under the agreement, Amgen will be primarily responsible for developing, manufacturing

and initially commercializing the products, while Watson will put in up to $400m in co-

development costs and will share product development risks. Biosimilars from the

collaboration are expected to be sold jointly by both companies.

Amgen has secured a clause which prevents the collaboration from making biosimilar

versions of its drugs including Enbrel (etancercept), Aranesp (darbepoetin alfa) and

Epogen (epoetin alfa).

This deal gives the opportunity to Amgen to enter the biosimilars arena, to develop his

know how and to know more how his can protect his product, Neupogen.

23/05/2016 47

Prescription


6 Prescription

The new European regulations promote this strategy by granting one year

additional exclusivity for products that laboratories decided to switch to OTC.

Pharmaceutical laboratory make the drug available without a prescription and

bet on attachment to the brand.

The Claritin (loratadine ) medicine of the laboratory MSD became OTC in the

United States in November, 2002. Generic version entered on the market in the

end of December, 2002.

23/05/2016 48

The evolution of sell of Neupogen from 2008 to 2014


1,41,2

0

0,4

0,8

1,2

2008 2014

Bill

ion

$

Sales of Neupogen

23/05/2016 49

GLOBAL ECONOMIC SITUATION: Reduction of health spending


23/05/2016 50

Anti-TNF, Insulins and Onco MABs are the key biologics

Source: IMS


23/05/2016 51

NAMING


23/05/2016 52

COMPARISON OF DIFFERENCE AND COMMON POINTS BETWEEN

BIOSIMILARS AND GENERICS-STRUCTURE

KEY POINTS BIOSIMILARS Generics

NatureDrug extracted from a biological

environmentChemical drug

Molecular size Up to 270,000 Da 100 to 200 Da

Development Comparative studies Bioequivalence studies

Duration of development 5-7 years(500 patients) 2-3 years (20-50 patients)

Cost of the development 200-300 million dollars 2-4 million dollars


23/05/2016 53

TOP DRUG-PATENT EXPIRE


23/05/2016 54

MARKET TRENDS: Global picture

KEY POINTS DIFFERENCE IDENTICAL

The leading countries x

Market value x

Number of product x

Production cost x

Comparison between Biosimilars and Generics

Focus on EU :

Most advanced market 80% of global spending in 2011 11% of total biologics sales in 2011 50% of the off-patent biological market in 2020

Countries Sales in volume(M)

Sales in value( M€)

Germany 6,1 68

France 2,7 40

Italy 2,5 22

UK 0,5 19

Biosimilars market in volume and value in 2011


Source: IMS

23/05/2016 55

THE FUTURE BIOSIMILARS


23/05/2016 56

BIOSIMILARS MARKET IN VOLUME AND VALUE


23/05/2016 57

STRATEGIES OF PHARMACEUTICAL COMPANY TO PROTECT THE

PLACE OF THEIR MEDICINE-(GENERICS)

DCI LaboratoryName

Patent LegalActions

Product Brand Strategy

Amoxicilline-acide

clavulanique

GlaxoSmith-Kline X X X

Buspirone Bristoll MyersSquibb

X X

Gabapentine Pfizer X X XOmeprazole Astra

ZenecaX X X


23/05/2016 58

MANUFACTURING OF BIOSIMILARS

Un processus de fabrication en 6 étapes:

Les biosimilaires sont composés de protéines recombinantes dont la fabrication se décline en 6 étapes. Chacune de ces étapes implique d’importants efforts en R&D et en contrôle qualité : les propriétés thérapeutiques des molécules dépendent fortement de leur processus de fabrication.

1. Sélection du gène et de la cellule-hôte

2. Création d’une culture cellulaire à partir d’une banque de cellules

3. Synthèse de la protéine recombinante par les cellules hôtes

4. Purification de la protéine synthétisée

5. Formulation du médicament

6. Conditionnement pharmaceutique


23/05/2016 59

REFERENCE

1. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html

2. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS

3. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp

4. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

5. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

6. Shaping the biosimilars opportunity-december 2011

7. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html

8. Rapport 2012 sur les médicaments génériques-Mutualité Française

9. EMA Procedural advice for users of the centralized procedure for generic/hybrid applications

10. Lessons learned from the review of the labelling of 5 centrally authorised pandemic vaccines- 10 February 2014 EMA

11. Rapport 2012 sur les médicaments génériques- Mutualité Française

12. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration

13. http://ec.europa.eu/health/authorisation-procedures_en.htm

14. Guideline on the investigation of bioequivalence- London, 20 January 2010- European Medicines Agency

15. http://www.australianprescriber.com/magazine/26/4/article/712.pdf

16. Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC

17. Biosimilars Marketing Authorisation status as of January 2013: 22 Marketing Authorisation Applications

18. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp

19. Individual case safety report: Article 28 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012

20. Biological Qualifier An INN Proposal-July 2014- World Health Organization, Geneva

21. http://www.gabionline.net/Biosimilars/Research/Improved-labelling-sought-for-biosimilar-acceptance

22. EC consensus paper 2013- What you need to know about Biosimilar Medicines

23. European Commission consensus paper 2013 : What you need to know about biosimilar medicines

24. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration

25. http://gabionline.net/Biosimilars/Research/Extrapolation-for-biosimilars

26. Directive 2001/83/CE du parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux

médicaments à usage humain

27. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS

28. http://healthcare.blogs.ihs.com/2012/01/06/generic-drug-price-trends-france-germany-italy-spain-uk/


23/05/2016 60

REFERENCE


23/05/2016 61

REFERENCE


23/05/2016 62

QUESTIONS FOR THE INTERVIEWS

1. Generally, a comparison is made between Biosimilars and Generics in terms of regulation, market

penetration and sales. According to you, what are the aspects of Biosimilars comparable to Generics, and

which ones are not?

2. In Europe, Germany is the largest market for Biosimilars. According to some, this advance may be

explained partly by price regulation and Biosimilars repayment terms in Germany. In your opinion, what is

the role of regulation in the European market for Biosimilars?

3. The name of a medication is an important element. It allows their differentiation and reassure

patients. Regarding Biosimilars, the World Health Organisation has chosen to develop a four-letter code at

the end of the name (for instance: epoetin alfa bbbb). This code is entitled to differentiate Generic and

Originators from Biosimilar. What do you think of this approach?

3.1 Some professionals believe that this differentiation will hamper the substitution needed to reduce

health care costs. What is your opinion?

3.2 Will this naming system allow to more easily track the adverse effects that could be included in the

patient records?

3.3 Do you think of other advantages or disadvantages related to this approach?

4. Instructions accompanying medication provides important information for its proper use and for

patient safety. Do you think the instructions of a Biosimilar should provide the same information as the ones

of the Generic or Originators it replaces?

4.1 In order to strengthen trust, some associations recommend a combination of information about

each Biosimilar and the reference product in the record. What is your opinion regarding this proposal?

4.2 Will not a different instruction between the Biosimilar and reference lead the prescriber to the

conclusion that Biosimilars do not require the same level of proof that their reference products?

4.3 Do you see other advantages or disadvantages in the fact of differentiating instruction of a Biosimilar

from the one of its reference product?


23/05/2016 63


5. Some reference products already commercialised are used in several therapeutic indications.

Regarding Biosimilars, is such a use desirable?

5.1 If extrapolation is desirable, is conducting a clinical study necessary?

5.2 If not, is it necessary to implement the same approach, which is used for Generics? (Meaning setting

up bioequivalence studies?)

6. In France, Italy, and in Germany, the replacement of a medication by a Generic is possible through a

pharmacist. Do you think that this process should be extended to Biosimilars?

6.1 In your opinion, is replacement by Biosimilar not going to threaten medication’s traceability, and thus

the identification of the origin of undesirable reactions in the patient?

6.2 The process of substitution requires the creation of a regulatory basis for interchangeability criteria. Do

the expected benefits of such regulations allow you to justify the costs and regulatory risks borne by the

stakeholders (government and companies)?

7. In Germany, in some cities such as Bremen, a quota system encouraging doctors and health insurance

fund to use Biosimilars has been set up. It is translated into an increase in the prescription of Biosimilars in this

town. What is your point of view regarding the set-up of quotas or call for tender for Biosimilars?

7.1 As part of a call for tender, if a company wins a two-year contract, there is little incentive for

competitors to produce. If the provider chooses not to meet its obligations, there is a risk of supply disruption.

Do you think that it is a major issue in your country? What would you consider the best way to prevent this

situation?

7.2 In order to improve the penetration of Biosimilar in various countries, would not it be more effective to

communicate to physicians and suppliers about the high quality standards for Biosimilars? What would be

according to you the best way to answer it?


23/05/2016 64


8. In 2013, on the world scene the Biosimilars market accounted for $ 1.3 billion of which 80% in

Europe. By 2020 it will account for $ 25 billion. According to you, what will be the evolution of this

market in the upcoming years in Europe, especially in France, Germany, Italy and in the United

Kingdom?

9. The introduction of Generics has significantly reduced medication prices. For instance, in Germany

the decrease can reach of 71%. Regarding Biosimilars, may we expect such a decrease?

10. With Biosimilars and Generics being present on the market, do you think that Originators

medications will keep their leadership in France, Germany, Italy and in the United Kingdom?


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BIOSIMILARS - Regulation and Market Trends

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