BIOSIMILARS.pptx

introduction to biosimilar drug
difference between biosimilars and generic drugs
global scenarios
Indian scenario
conclusion

1. BIOSIMILARS PRESENTED BY: Rutuja P. Rane M. Pharm 1 st year resident Pharmacology

2. CONTENTS Terminologies Introduction History Biosimilars Biosimilars Vs Generics Manufacturing Regulation Global Scenarios Conclusion

3. Terminologies Biological products – Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecules drugs. Active Pharmaceutical Ingredient (API) - A substance or compound that is intended to be used in the manufacture of pharmaceutical product as a therapeutically active compound.

4. 3. Biologics - A therapeutic agent manufactured in a living system such as a microorganism or plant or animal cell using recombinant DNA technology. 4. Generic – A Generic drug is a pharmaceutical drug that contains the same chemical substance as drug that was originally protected by chemical patents.

5. What are “BIOSIMILARS”? Biosimilars are defined as a bio- therapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biological product. Almost identical copy of an original biological product They are large molecules with complex structures They are prepared from engineered organisms Eg. : Insulin produced from E.coli

6. ORGANISATION TERM DEFINITION WHO SBP (Similar Biologic Product) Similar to an already licensed reference biotherapeutic product in terms of quality, safety & efficacy. US-FDA FOB ( Follow-On Biologic) Highly similar to reference product without clinically meaningful differences in safety, purity and potency. HEALTH CANADA SEB (Subsequent Entry Biologic) Drug that enters the market subsequent to a version previously authorised in Canada with demonstrated similarity to a reference biologic product.

7. History In late 1960’s , the FDA developed the abbreviated new drug application for approval of generic drug. The 1 st ever “similar biologic “ product manufactured by India was a Hep- B vaccine named BIOVAC B in 2000. The 1 st biosimilar approved by EMEA was OMNITROPE© which is a biosimilar Recombinant Human Growth Hormone in Year 2006. US-FDA manufactured 1 st follow up biologic Zarixo ( Filgastrim ) in 2015.

8. Biosimilars Include : Blood and Plasma products Non recombinant products Recombinant products Monoclonal antibodies Vaccines

9. Requirements for Biosimilars It should be biologic product Reference product should be an already licensed biologic product. The biosimilar should demonstrate a high similarity of safety, quality and efficacy to that of the reference product. Similarity should be determined by comparing the biosimilar product with the reference product based on quality, non clinical and clinical studies.

10. Are BIOSIMILARS Generic ? Biosimilars Generics Source Living organism Chemical synthesis Size Large molecule Small molecule Structure Complex, heterogenous Well defined Manufacturing process Difficult Relative simple Stability Unstable, sensitive to external conditions Stable Immunogenecity Immunogenic Mostly non immunogenic Bioequivalence with reference product No Yes Interchangable with reference product No Yes Cost High Low

11. Manufacturing Process

12. Difficulties in Production Barrier to entry to a biosimilar is way higher. Cost of manufacture is non trivial and not pennies. Only a handful of companies to produce a biosimilar Process patent are much difficult to break for generic companies. Often solo biosimilar company competing against the brand company.

13. Why produce Biosimilars? When the patent goes off/expire. ⁞ Its not easy for other companies to start making generic version ⁞ Patent holder to give his engineered organism to anyone ⁞ Other companies will have to try to replicate the engineered organism.

14. Concerns with Biosimilars Efficacy Safety Pharmacovigilance Substitution Naming and labelling

15. Regulatory Framework The regulatory pathway for approval of Biosimilars is more complex than for the generic products because of the design of scientifically valid study to demonstrate the similarity of a highly process dependent product is not easy. The main regulatory bodies around the world are : European Union’s EMEA ( European Medicines Evaluation agency) America’s US FDA ( United States Food and Drug Administration) India’s CDSCO ( Central Drug Standard Control Organization)

16. EMEA Scenario First recommendation in 2005, revised in 2015. EMA guideline 2015 recommends a stepwise conduct of non clinical and clinical studies. Non clinical studies includes Binding capacity Signal transduction and Potentially relevant differences comparison.

17. Clinical studies includes – Pharmacokinetic and pharmacodynamic studies Clinical trial of patient population Choice of clinical endpoint in efficacy trial Evaluation of the immunogenicity of the biosimilars Pharmacovigilance studies

18. US – FDA Scenario in the US, after the approval of biosimilar OMNITROPE in 2006, the FDA stated that no other biosimilar will be approved until a specific regulation has been issued. In Feb 2012 FDA issued 3 draft guideline documents which include: Scientific consideration Quality consideration Question and answers (regarding the Implementation of the biologics Price Competition and Innovation Act of 2009.)

19. Indian Scenario August 2016 “ guidelines on Similar Biologics : Regulatory Requirements for marketing authorization in India “ Approval of clinical trials as well as new drugs. Permission for import of drugs for clinical trial. Export of clinical samples for biochemical and immunological analysis. Permission for marketing and manufacture.

20. Biosimilar Industries around the World Country Companies Products USA Sandoz, Pfizer, Phage Biotech GH, Heparin, calcitonin EUROPE Teva, Hexal , GSK Somatotropin, GH JAPAN Ranbaxy, Otsuka , nippon kayaku GH, Zentoech CANADA Cangene , Biocon, Sandoz HGH, Insulin CHINA Genescience , Shenzen Insulin , mABs , GH S. KOREA LG Lifesciences, Boryoung group Epogen, HGH, follitropin

21. Biosimilar Industries in India Cipla Lupin Biocon ltd. Cadila Healthcare Dr. Reddy’s laboratories Growth hormone, erythropoietin, Insulin, monoclonal antibodies, streptokinase etc.

22. Conclusion Biosimilars are boon to the health care system as well as to the economy. Biosimilars provide ample opportunities to the industry for producing medicines at a lower cost. Concern regarding the long term adverse effects of the drugs remain . A stringent post marketing survellience plays a pivotal role.

23. Thank you!!