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Understanding Biosimilars: Opportunities and Challenges in Biopharmaceuticals

This presentation by Anshul Sharma explores the concept of biosimilars, emphasizing their importance in the biopharmaceutical industry. Coined by the European Medicines Agency, biosimilars serve as cost-effective alternatives to biologics, particularly following the expiration of patents on blockbuster drugs. The presentation discusses the classification, regulatory framework, and market dynamics surrounding biosimilars, highlighting their potential to enhance affordability in healthcare while addressing the challenges of similarity and comparability to innovator products. Key insights into the Indian biopharmaceutical landscape are also presented.

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Understanding Biosimilars: Opportunities and Challenges in Biopharmaceuticals

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  1. Biosimilars • A Presentation • By • ANSHUL SHARMA • Graduate Research Scholar • Deptt. Of Biochemical Engg & Biotechnology, • Indian Institute of Technology, Delhi

  2. Biosimilars • Coined by EMA (European Medicine Agency) • Bio-betters • Similar Biological Products (SBP) • Follow-on bioproducts • “Generics of Bio-pharmaceutical Industry” • Caution : Not alternative biologics

  3. The Fuzz…. Massive Patent expiration for Blockbuster Innovator biologics by 2016 (~ $25bn Market Cap) Eg. Herceptin, Rituxan Increased pressure of affordability of biologics on sales of companies and health budgets of govt. Cerezyme (Gaucher Disease) : $200000 per patient per annum Herceptin (Breast Cancer ) : $30000 per patient per annum • Make cheaper biologics • Remove monopolies and bring competitiveness in market

  4. Loss of Patent Protection AROUND $25bn Market Source : Analysis Group Health Care Consulting Bulletin (Fall/Winter 2010)

  5. Biosimilars As A Healthcare Concept Layers of “The Concept” – ( Interlocked Layers ) • Scientific Layer • Concept of similarity in term of bio-characterization, potency, safety & effect w.r.t innovator molecule • Predictable PK & PD based on data for reference compound • Regulatory Layer • Faster & Easier approval route • Early market entry, • Reduced Clinical trial requirements (extrapolation on basis of data available for the innovator molecule ) • Market and Social Layer • Established & Larger Market Base and distribution channels • Cost- Demand trade off, • Increased Profit Margins for sponsors • Affordability

  6. WHERE DOES THIS DIFFERENCE COMES FROM ? Sources of variation between manufacture of innovator biopharmaceutical and Biosimilars Source: Misra M , Biosimilars: current perspectives and future implications, Indian J Pharmacol..,2012 Jan;44(1):12-4. .

  7. Global Market

  8. Global Market Source: Article on: Biosimilar Market Posts Steady Gains ,Genetic Engineering & Biotechnology News dated Jun 15, 2012 (Vol. 32, No. 12) Original : BCC Research

  9. Why Developed Market like US need Biosimilars ? • Load of existing biologics on the National Health Insurance Budget Biological Price Competition and Innovation Act, 2009 (BPCI) Impact : Source: Congressional Budget Office Estimate, 2008 Medicaid spending Tax Deficit Total expenditure (biologics ) • $ 4bn • (2013) • $6.6bn • (2013) • $25 bn • (2018)

  10. US FDA • Lag behind EMA on Approval and Guidelines on Biosimilars • Obama Administration : • Decrease BPCI set data exclusivity limit to 7 years from existing 12 years in 2012-13 FY. (SAVING OF  $4 billion over 10 years) • Opposition from Drug developers (Issue in Supreme Court)

  11. List of Biosimilars (as of 9/11/2012) Source : EMA website

  12. Lets come back to India • Emerging Biopharma hub , Robust Manufacturing Base • Itself a big market, semi-regulated (Easier market entry + High demand = PROFITS) • Regulation Central Drug Standard Control Organization CDSCO & DBT recently drafted Pre-market Regulatory Compliances : Guidelines on Similar Biologics (2012)

  13. Indian Players in Biosimilars • Trends • Target Markets : Domestic + Developed Market ( as Contract Manufacturers) • Stronger Acquisition Strategy : Capacity Building for production • Aiming for Regulated Markets like US and EU also • Strong Response to Tap Opportunity from: Biocon, Dr. Reddy’s Lab., Wockhardt, Cipla Pharmaceuticals • Partnerships Merck Serono Enters Biosimilar Segment in Deal with Dr. Reddy's, Jun 7, 2012, GENNewsHighlights (A WIN-WIN SITUATION)

  14. Indian Players

  15. Hurdles • Proper Regulatory structure not in place yet. • A competitive edge to original manufacturer (good knowledge base for manufacturing a Biosimilars based on innovator biologic production) • Proof of Similarity and comparability to innovator product requires very hectic characterization. (LOT OF ANALYSIS COMPARED TO GENERICS ) A lot of Analytic Techniques required for validation ( IEX (charge), RPLC, SEC, AXC , CE etc )

  16. What can be done ? • Post Approval Risk Plan - Strong communication between front end of healthcare system (Doctors) to the manufacturer and regulatory authorities. • Continuation of post approval trials • Option between a well established (but costly) biologics and A newly introduced Biosimilars should be left to patient’s will. • Streamlined regulatory pathways for global platform

  17. THANK YOU FOR YOUR PATIENCE !!! -Anshul sharma

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