Unlock Their Potential Biosimilars, the key to driving access and sustainability

Biologics have revolutionized the treatment of many disabling and life-threatening diseases; however their high costs place a significant burden on healthcare systems and sometimes hinders patient access.1

Proactive reforms to strengthen health systems and alleviate future pressures will be needed to address future challenges, especially post-COVID-19.

Growing uptake of biosimilars has delivered significant benefits to healthcare systems since its approval in 2006, aiming to:1,3,4,8

• Increase patient access by allowing biologics to be used earlier in the

treatment journey • Allow health systems to redirect funds so more patients can be treated • Contribute to building sustainable health care systems • Stimulate innovation in development of next-generation biologics• Drive competition, resulting in increased treatment options and value-added

services to support patient care and the healthcare community

April 2021 marks the 15-year anniversary of the world’s first approval of a biosimilar 9

Sandoz is committed to further unlocking the potential of biosimilars and increasing the number of patients who are able to access the benefits of biologics by:

..however uptake of biosimilars varies greatly not only across countries and therapy areas, but also within countries:

What are biosimilars?

Good progress has been made..

Biosimilars have made a significant di�erence but a lot more still needs to be done

Reference

Why biosimilars?

15+ years of impact by Sandoz biosimilars

of new drug approvals are expected to be

biologic products by the year 2025.2

Global spending on healthcare will

double by 20403

Over 70% $24.24 trillion

1. Dutta, B., et al. Identifying Key Benefits in European O�-Patent Biologics and Biosimilar Markets: It is Not Only About Price. BioDrugs (2019).

2. Chemical and Engineering News. Untangling Biosimilars. Available at: https://cen.acs.org/articles/88/i48/Untangling-Biosimilars.html. Accessed April 2021.

3. Future and potential spending on health 2015–40. The Lancet May 2017.4. European Commission. Consensus Information Paper 2013. What you need

to know about Biosimilar Medicinal Products. Available from: http://ec.eu-ropa.eu/DocsRoom/documents/8242/attach-ments/1/translations/en/renditions/native. Accessed March 2021.

5. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7

6. Food and Drug Administration. Biosimilars [online]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrug-sareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/. Accessed March 2021.

7. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products) [online]. Available from: https://www.medicinesforeurope.com/wp-content/up-loads/2016/03/WC500020062.pdf. Accessed March 2021.

8. Institute of Management Services. Delivering on the promise of biosimilar medicines: The role of functioning competitive markets [online]. Available from: https://www.medicinesforeurope.com/wp-content/up-loads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed March 2021.

9. European Medicines Agency. Omnitrope® Summary of Product Characteris-tics. Available from:http://www.ema.europa.eu/docs/en_GB/document_li-brary/EPAR_-_Product_Information/human/000607/WC500043695.pdf. Accessed March 2021.

10. European Medicines Agency. European public assessment reports. Available from: https://www.ema.europa.eu/en/medicines/. Accessed March 2021.

11. Rios, M. A Decade of Microbial Fermentation. Available from:http://www.bio-processintl.com/upstream-processing/fermen-tation/a-decade-of-microbial-fermentation-331179/ [Accessed March 2020].

12. Sandoz Biosimilars [online]. Available from: https://www.san-doz.com/our-work/biopharmaceuticals/sandoz-biosimilars. Accessed March 2021.

13. Date on file.14. PSUR data on file.15. ProBiosimialrs. New study shows: Rheumatoid patients have faster access to

biological therapy since biosimilars exist. Available from: https://probiosimi-lars.de/presse/versorgung/studie-biologika-und-rheuma-patienten/. Accessed March 2021.

16. Association for Accessible Medicines. 2020 Generic Drug & Biosimilars Access & Savings in the U.S. Report. September 29, 2020. https://accessi-blemeds.org/sites/default/-files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf. Accessed April 2021.

17. IQVIA Institute for Human Data Science. Biosimilars in the United States 2020–2024. Published September 29, 2020. Accessed April 2021.

18. Government of Canada. Biologics in Canada. Part 2: Biosimilar Savings, 2018. Available at: https://www.canada.ca/en/patented-medicine-prices-review/-services/reports-studies/biologics-part2-biosimilar-savings2018.html. Accessed March 2021.

19. ESNO. Switch Management between similar biological medicines. Available from https://www.esno.org/assets/files/biosimilar-nurses-guide-line-final_EN-lo.pdf. Accessed April 2021.

20. NHS England » The NHS saves £324 million in a year by switching to better value medicines. Available from: https://www.england.nhs.uk/2018/07/n-hs-saves-324-mil-lion-year-switching-to-better-value-medicines/#:~:text='By%20delivering%20%C2%A3324%20million,to%20be%20achieved%20this%20year.. Accessed March 2021.

21. National Health Service Reports Substantial Savings From Biosimilar Adalimumab (centerforbiosimilars.com). Available from: https://www.center-forbiosimilars.com/view/nhs-biosimi-lars-will-save-an-additional-131-million-this-year. Accessed March 2021.

22. Urru, M. A. et al. Safety of switching between rituximab biosimilars in onco-hematology. Scientific Reports 2021; 11:5956.

23. IQVIA. Biosimilar Score Card 2020 France. Available from: https://ww-w.iqvia.com/-/media/iqvia/pdfs/institute-re-ports/country-scorecards-for-biosimilar-sustainability/iqvia-biosimilar-scorecard-france.pdf?la=en. Accessed March 2021.

24. Biosimilars Saved Spain 2,400 Million Euros Between 2009 and 2020. Available at: https://www.eversana.com/2020/05/06/spain-biosimilar-sav-ings/. Last accessed: March 2021.

25. European Commission. (2020). Pharmaceutical Strategy for Europe. Publication No. COM(2020) 761 final. Published November 2020. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CEL-EX:52020DC0761&from=EN. Accessed March 2021.

Copyright Sandoz - 2021

• A follow-on medicine to a biological medicine (“reference medicine”) for which the patent has expired and exclusivity has been lost.4,5

• Matches the reference medicine in terms of safety, quality and e�cacy, so physicians and patients can expect the same clinical outcome.1,6

• Biosimilars are approved by the same regulatory authorities and are manufactured following the same high-quality standards as for the reference biologic.3,7

Sandoz biosimilars used in clinical practice for

15 years10

>20 years’ experience in biosimilar research and development, more than any other biosimilar manufacturer 9

Since the 1980s, Sandoz has been developing recombinant proteins 11

In 1996,Sandoz started the world’s first biosimilar development program

8 marketed biosimilars, across immunology, oncology and endocrinology 10

>15 molecules in pipeline, adding at least one new per year 12

Sandoz biosimilars available in

100 countries13

730 million+ patient days of experience 14

Germany Rheumatoid arthritis patients had to wait 7.4 years to be treated with a biologic, after the introduction of numerous biosimilars in this space, this number is down to 0.3 years. 15

CanadaThe Patented Medicines Prices Review Board has anticipated that new biosimilars entering the market could generate a total savings varying from USD 222-447 million by 2023. 18

France Government initiative set up in place to increase biosimilar penetration to 80% by 2022. 23

Italy The hematology unit of a hospital saved 45% by switching to biosimilars in one year, with an absolute savings of approximately EUR 400,000. 22

UKNHS England saved GBP 324 million through use of biosimilars in 2017/1820 and aims to save GBP 400-500 million by 2020/21. 21

BelgiumIn a hospital, patients with inflammatory bowel disease switched to a biosimilar (with the emphasis on keeping them informed and educating them), freeing up resources to treat more patients and extend nursing care. 19

SpainBetween 2009 and 2020, cancer and inflammatory therapy areas generated savings of EUR 2.4 billion due to the entry of biosimilars. 24

US Biosimilars savings totaled USD 2.2 billion in 2019 and USD 4.5 billion over the past 10 years. 16 The momentum is growing, over 5 years (2020-2025) there is the potential to save USD 100 billion. 17

Improving awareness and understanding of

the value of biosimilars

Accelerating uptake for biosimilars by

putting learnings from countries into practice

Fostering competition by developing and

launching new biosimilars

Working with stakeholders to

overcome barriers to greater biosimilars

uptake

Supporting initiatives by bodies like the European Commission’s Pharmaceutical Strategy for Europe which aims to address inequalities in access to a�ordable and safe medicines 25

15 years on and despite proven benefits for patients and healthcare systems, there remain hurdles to unlock the full potential of biosimilars.

Together we can help drive a�ordability and sustainability in a post COVID-19 world.

Stakeholders in healthcare need to team up to: • Improve awareness and understanding of the value of biosimilars amongst

physicians and patients • Fight misinformation about biosimilars• Address inequalities in access to biologics across and within countries • Adopt policies that encourages the use of biosimilars, while making sure to

stimulate long term sustainability of the health care systems• Create a sustainable framework to address emerging challenges of a post

COVID-19 world