bio similars
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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 - PowerPoint PPT PresentationTRANSCRIPT
Biosimilars
A Presentation By
ANSHUL SHARMAGraduate 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
• “Generics of Bio-pharmaceutical Industry”
• Caution : Not alternative biologics
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 annumHerceptin (Breast Cancer ) : $30000 per patient per annum
• Make cheaper biologics• Remove monopolies and bring competitiveness in market
Loss of Patent Protection
Source : Analysis Group Health Care Consulting Bulletin (Fall/Winter 2010)
AROUND $25bn Market
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
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..
Global Market
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
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
Tax Deficit
- $6.6bn(2013)
Total expenditure (biologics )
- $25 bn
(2018)
Medicaid spending
- $ 4bn(2013)
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)
Brand Name Active substance Date of authorisation / refusal Status
Abseamed epoetin alfa 28/08/2007 Authorised
Alpheon recombinant human interferon alfa-2a 22/10/2007 RefusedBinocrit epoetin alfa 28/08/2007 Authorised
Biograstim filgrastim 15/09/2008 Authorised
Epoetin Alfa Hexal epoetin alfa 28/08/2007 Authorised
Filgrastim Hexal filgrastim 06/02/2009 Authorised
Filgrastim ratiopharm filgrastim 15/09/2008 Withdrawn
Nivestim filgrastim 08/06/2010 Authorised
Omnitrope somatropin 12/04/2006 Authorised
Ratiograstim filgrastim 15/09/2008 Authorised
Retacrit epoetin zeta 18/12/2007 Authorised
Silapo epoetin zeta 18/12/2007 Authorised
Tevagrastim filgrastim 15/09/2008 Authorised
Valtropin somatropin 24/04/2006 Withdrawn
Zarzio filgrastim 06/02/2009 Authorised
Source : EMA website
List of Biosimilars (as of 9/11/2012)
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)
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)
Indian Players
Company Biosimilars in Pipeline/Market Remarks Source
Biocon RHI, mABsWanted to tap $17bn out of projected $20bn Insulin Biosimilars Market (2020)
CompanyAnnual ReportFY2011-12
Dr. Reddy’s Lab.Filgrastim , Rituximab , Darbepotin (Market)
G-CSF
Focus on EU Market,Merck –Reddy Deal Company
Website
Reliance Life Sciences Interferon alpha, beta , EPO, FSH, G-CSF, r-hCG , tPA
Subsidiary in Ireland Focus on EU market
CompanyWebsite
Lupin Releasing 2 by end of year -CompanyWebsite
Wockhardt Wosulin(Market)10 in Piipeline Early Enterant in Biosimilars
CompanyWebsite
Cipla Developing Heavy acquisition in China and Malaysia
CompanyWebsite
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 )
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
-ANSHUL SHARMA
THANK YOU FOR YOUR
PATIENCE !!!