Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.



Published on

  • Hi Anshul,
    Great piece of work. Can I have its PDF copy on
    Are you sure you want to  Yes  No
    Your message goes here
  • I am currently a MA student in pharmaceutical sciences, and I prepare Biosimilar Presentation, if possible help me by sending this Presentation as a reference to my email:, with thanks.
    Are you sure you want to  Yes  No
    Your message goes here
  • Dear can u send me this ppt or pdf of this ppt on my id
    Are you sure you want to  Yes  No
    Your message goes here


  1. 1. Biosimilars A Presentation By ANSHUL SHARMA Graduate Research ScholarDeptt. Of Biochemical Engg & Biotechnology, Indian Institute of Technology, Delhi
  2. 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. 3. The Fuzz…. Massive Patent expiration for Blockbuster Innovator biologics by 2016 (~ $25bn Market Cap) Eg. Herceptin, RituxanIncreased pressure of affordability of biologics on sales ofcompanies and health budgets of govt.Cerezyme (Gaucher Disease) : $200000 per patient per annumHerceptin (Breast Cancer ) : $30000 per patient per annum •Make cheaper biologics•Remove monopolies and bring competitiveness in market
  4. 4. Loss of Patent Protection AROUND $25bn Market Source : Analysis Group Health Care Consulting Bulletin (Fall/Winter 2010)
  5. 5. Biosimilars As A Healthcare Concept Layers of “The Concept” – ( Interlocked Layers )  Scientific Layer • Concept of similarity in term of bio-characterization, potency, safety & effect w.r.t innovator molecule • Predictable PK & PD based on data for reference compound  Regulatory Layer • Faster & Easier approval route • Early market entry, • Reduced Clinical trial requirements (extrapolation on basis of data available for the innovator molecule )  Market and Social Layer • Established & Larger Market Base and distribution channels • Cost- Demand trade off, • Increased Profit Margins for sponsors • Affordability
  6. 6. WHERE DOES THIS DIFFERENCE COMES FROM ? Sources of variation between manufacture of innovator biopharmaceutical and BiosimilarsSource: Misra M , Biosimilars: current perspectives and future implications, Indian J Pharmacol..,2012 Jan;44(1):12-4.
  7. 7. Global Market
  8. 8. Global Market Source: Article on: Biosimilar Market Posts Steady Gains ,Genetic Engineering & Biotechnology News dated Jun 15, 2012 (Vol. 32, No. 12) Original : BCC Research
  9. 9. Why Developed Market like US need Biosimilars ? • Load of existing biologics on the National Health Insurance Budget Biological Price Competition and Innovation Act, 2009 (BPCI) Impact : Medicaid Tax Deficit Total expenditure spending (biologics ) -$ 4bn (2013) -$6.6bn (2013) Source: Congressional Budget Office Estimate, 2008 -$25 bn (2018)
  10. 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 12years in 2012-13 FY. (SAVING OF $4 billion over 10 years)•Opposition from Drug developers (Issue in Supreme Court)
  11. 11. List of Biosimilars (as of 9/11/2012) Date of authorisation /Brand Name Active substance Status refusalAbseamed epoetin alfa 28/08/2007 AuthorisedAlpheon recombinant human interferon alfa-2a 22/10/2007 RefusedBinocrit epoetin alfa 28/08/2007 AuthorisedBiograstim filgrastim 15/09/2008 AuthorisedEpoetin Alfa Hexal epoetin alfa 28/08/2007 AuthorisedFilgrastim Hexal filgrastim 06/02/2009 AuthorisedFilgrastim ratiopharm filgrastim 15/09/2008 WithdrawnNivestim filgrastim 08/06/2010 AuthorisedOmnitrope somatropin 12/04/2006 AuthorisedRatiograstim filgrastim 15/09/2008 AuthorisedRetacrit epoetin zeta 18/12/2007 AuthorisedSilapo epoetin zeta 18/12/2007 AuthorisedTevagrastim filgrastim 15/09/2008 AuthorisedValtropin somatropin 24/04/2006 WithdrawnZarzio filgrastim 06/02/2009 Authorised Source : EMA website
  12. 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. 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• PartnershipsMerck Serono Enters Biosimilar Segment in Deal with Dr. Reddys, Jun 7, 2012, GENNewsHighlights (A WIN-WIN SITUATION)
  14. 14. Indian PlayersCompany Biosimilars in Pipeline/Market Remarks Source Wanted to tap $17bn out of CompanyBiocon RHI, mABs projected $20bn Insulin Annual Report Biosimilars Market (2020) FY2011-12 Filgrastim , Rituximab , Darbepotin (Market) Focus on EU Market, CompanyDr. Reddy’s Lab. Merck –Reddy Deal Website G-CSF Company Interferon alpha, beta , EPO, FSH, G-CSF, Subsidiary in IrelandReliance Life Sciences Website r-hCG , tPA Focus on EU market CompanyLupin Releasing 2 by end of year - Website Company Wosulin(Market)Wockhardt Early Enterant in Biosimilars Website 10 in Piipeline Company Heavy acquisition in China andCipla Developing Website Malaysia
  15. 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. 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