General overview on Biosimilars Drug Products

This ppt provides brief information on: What Are Biosimilars?, Biosimilars V/S Biologics, Key Characteristics Of Biosimilars, Why Are Biosimilars Being Developed?,Process And Data Required For Approval Of Biosimilar Drug Products,
Examples Of FDA Approved Biosimilars,The Future Of Biosimilars

1. Overview on Biosimilar drug products PRESENTED BY – KAUNAIN FATHEMA M. Pharm, Sem II Department of Pharmaceutics GOKARAJU RANGARAJU COLLEGE OF PHARMACY Affiliated to OSMANIA UNIVERSITY TELANGANA UNDER THE GUIDANCE OF – Dr. G. SAILAJA M. Pharm., Ph.D. ASSOCIATE PROFESSOR Department of Pharmaceutics

2. content What Are Biosimilars? Biosimilars V/S Biologics Key Characteristics Of Biosimilars Why Are Biosimilars Being Developed? Process And Data Required For Approval Of Biosimilar Drug Products Examples Of FDA Approved Biosimilars The Future Of Biosimilars References 2

3. WHAT ARE BIOSIMILARS? A biosimilar product is a biological product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Biosimilars are safe and effective biological medications for treating many illnesses, including chronic skin diseases, such as psoriasis; inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis; arthritis; kidney conditions; diabetes; and cancer. These medications can provide more treatment options and potentially reduce costs for patients. 3

4. OFFICIAL DEFINITIONS The European Medicine Agency - A biosimilar is a biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’). When approved, a biosimilar’s variability and any differences between it and its reference medicine will have been shown not to affect safety or effectiveness. The United States Food and Drug Administration - A biosimilar is a biological product that is highly similar to a US licensed reference biological product not withstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product. The World Health Organization - A biosimilar is a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. 4

5. BIOSIMILARS v/s BIOLOGICS BIOLOGICS- Biological products, or biologics, are generally large, complex molecules that are made from living sources such as bacteria, yeast, and animal cells. 5

6. BIOSIMILARS Similar to biologics, not identical Competitive bioequivalence Almost 8-9 years to develop $100-200 million cost Non-patentable Reduced Price BIOLOGICS Produced from living organisms Novel therapeutic product Almost 15 years to develop $1.2 billion cost Patentable Reference Price 6

7. KEY CHARACTERISTICS OF BIOSIMILARS High Similarity to Reference Medicine: A biosimilar is a biological medicine that closely resembles another already approved biological medicine (known as the “reference medicine”). It shares a high degree of structural similarity, biological activity, efficacy, safety, and immunogenicity profile with the reference medicine .   Regulatory Approval Standards: Biosimilars undergo rigorous evaluation by regulatory agencies (such as the European Medicines Agency in the EU or the FDA in the US). They must meet the same standards of pharmaceutical quality, safety, and efficacy as all biological medicines . 7

8. Not Identical to Generics: Unlike generic drugs, biosimilars cannot be exact replicas due to the natural variability and complex manufacturing processes of biological medicines. Molecular micro-heterogeneity prevents an identical replication. Clinical Experience and Safety: Over a decade of clinical experience shows that biosimilars approved through regulatory agencies can be used safely and effectively in all approved indications. Biosimilars are considered as safe and effective as other biological medicines. 8

9. WHY ARE BIOSIMILARS BEING DEVELOPED? Cost Effectiveness Increased Access Regulatory Support Clinical Efficacy Patent Expiry 9

10. Cost-Effectiveness : They are generally less expensive than original biologics, making treatments more affordable. Increased Access : By providing more treatment options, biosimilars improve patient access to essential medications. Patent Expiry : When patents on original biologics expire, biosimilars can be developed and marketed. Regulatory Support : Regulatory frameworks, like the Biologics Price Competition and Innovation Act (BPCIA), facilitate the development and approval of biosimilars. Clinical Efficacy : They offer similar clinical efficacy and safety profiles as their reference biologics. 10

11. DATA REQUIRED FOR APPROVAL PROCESS OF BIOSIMILARS 11

12. Analytical studies : Comparative analytical data provide the foundation of biosimilar development. These studies provide data to support the structural and functional similarity of the proposed product to the reference product and to evaluate the impact of any differences identified. Animal studies : These may provide toxicology or pharmacology information. C linical Pharmacology studies : Pharmacology studies may demonstrate that the proposed biosimilar moves through the body in the same way and provides the same effects as the reference product. An ‘immunogenicity assessment’ evaluates a patient’s immune response to the proposed biosimilar. Additional Clinical studies: Other comparative clinical studies are sometimes conducted after the completion of other studies to address any remaining uncertainty about whether the proposed biosimilar has any clinically meaningful differences from the reference product. 12

13. BIOSIMILARS APPROVAL PROCESS Standalone and Abbreviated FDA approval pathway for Biosimilar drug products   13

14. Examples of biosimilars Herceptin A lso known as Trastuzumab I s an injectable biologic medication. P roduced from living or natural resources, such as bacteria, proteins, or sugars. G iven as an intravenous (IV) infusion by itself or in combination with chemotherapy. A pproved to treat certain types of HER2-positive breast cancer and HER2-positive stomach cancer. BIOSIMILAR NAME APPROVED IN OGIVRI DEC 2017 HERZUMA DEC 2018 ONTRUZANT JAN 2019 TRAZIMERA MARCH 2019 KANJINTI JUNE 2019 14

15. 2. ADALIMUMAB Also known as Humira (popular brand name). It is administered by subcutaneous injection. Adalimumab is a fully human monoclonal IgG1 antibody against tumor necrosis factor (TNF) α. Used to treat to treat various autoimmune conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. BIOSIMILAR NAME APPROVED IN AMJEVITA SEP 2016 CYLTEZO AUG 2017 HYRIMOZ OCT 2018 HADLIMA JULY 2019 ABRILADA NOV 2019 HULIO JULY 2020 YUSIMRY DEC 2021 IDACIO DEC 2022 YUFLYMA MAY 2023 15

16. THE FUTURE OF BIOSIMILARS Looking ahead, the biosimilars sector is expected to experience continued growth, driven by the approval and launch of new products. The focus will increasingly be on next-generation biosimilars, which can offer greater efficacy, safety and patient convenience. In addition, sustainable manufacturing practices and personalized medicine will play a crucial role in the evolution of biosimilars. 16

17. references Sagar Kanase, Yogesh Gavhane , Khandekar A, Atul Gurav , Yadav A. Biosimilar: An Overview, International Journal of Pharmaceutical Sciences and Research. 2013 Jun 1;4(6):2132-2144. Agbogbo FK, Ecker DM, Farrand A, Han K, Khoury A, Martin A, et al. Current perspectives on biosimilars. J Ind Microbiol Biotechnol. 2019;46(9–10):1297–311. Jarab AS, Abu Heshmeh SR, Al Meslamani AZ. Examining the impact of biosimilar-to-biosimilar transition on effectiveness and safety. Expert Opin Biol Ther . 2024;24(7):563–6. Kumar R, Singh J. Biosimilar drugs: Current status. International Journal of Applied and Basic Medical Research. 2014;4(2):63. Sheridan M, Massich M, Nazanin Ashourian . Biosimilars. Journal of Infusion Nursing. 2024 Jan 1;47(1):19–29. 17

18. Kaida -Yip F, Deshpande K, Saran T, Vyas D. Biosimilars: Review of current applications, obstacles, and their future in medicine. World J Clin Cases. 2018;6(8):161–6. Ingrasciotta Y, Cutroneo PM, Marcianò I, Giezen T, Atzeni F, Trifirò G. Safety of biologics, including biosimilars: Perspectives on current status and future direction. Drug Saf . 2018;41(11):1013–22. Park SH, Park JC, Lukas M, Kolar M, Loftus EV. Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases. Intest Res. 2020;18(1):34–44. Misra M. Biosimilars: current perspectives and future implications. Indian J Pharmacol.2012;44(1):12–4. Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; Current status and future perspectives. J Pharm Bioallied Sci. 2019;11(1):12–5. 18

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