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Bio similars

Bio similars. A Presentation By ANSHUL SHARMA Graduate Research Scholar Deptt. Of Biochemical Engg & Biotechnology, Indian Institute of Technology, Delhi . Biosimilars. Coined by EMA (European Medicine Agency) Bio-betters Similar Biological Products (SBP) Follow-on bioproducts

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Bio similars

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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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