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 $25bn Market
Source : Analysis Group Health Care Consulting Bulletin (Fall/Winter 2010)
5. Biosimilars As A Healthcare Concept
Layers of “The Concept” – ( Interlocked Layers )
Scientific Layer
• Concept of similarity in term of bio-characterization, potency, safety & effect w.r.t
innovator molecule
• Predictable PK & PD based on data for reference compound
Regulatory Layer
• Faster & Easier approval route
• Early market entry,
• Reduced Clinical trial requirements (extrapolation on basis of data available for the
innovator molecule )
Market and Social Layer
• Established & Larger Market Base and distribution channels
• Cost- Demand trade off,
• Increased Profit Margins for sponsors
• Affordability
6. WHERE DOES THIS DIFFERENCE COMES FROM ?
Sources of variation between manufacture of innovator biopharmaceutical and Biosimilars
Source: Misra M , Biosimilars: current perspectives and future implications, Indian J Pharmacol..,2012 Jan;44(1):12-4.
8. Global Market
Source: Article on: Biosimilar Market Posts Steady Gains ,Genetic Engineering &
Biotechnology News dated Jun 15, 2012 (Vol. 32, No. 12)
Original : BCC Research
9. Why Developed Market like US need Biosimilars ?
• Load of existing biologics on the
National Health Insurance Budget
Biological Price Competition and Innovation Act, 2009 (BPCI)
Impact :
Medicaid Tax Deficit Total expenditure
spending (biologics )
-$ 4bn
(2013)
-$6.6bn
(2013)
Source: Congressional Budget Office Estimate, 2008 -$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)
Date of authorisation /
Brand Name Active substance Status
refusal
Abseamed epoetin alfa 28/08/2007 Authorised
Alpheon recombinant human interferon alfa-2a 22/10/2007 Refused
Binocrit 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
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
Company Biosimilars in Pipeline/Market Remarks Source
Wanted to tap $17bn out of Company
Biocon RHI, mABs projected $20bn Insulin Annual Report
Biosimilars Market (2020) FY2011-12
Filgrastim , Rituximab , Darbepotin (Market) Focus on EU Market,
Company
Dr. Reddy’s Lab. Merck –Reddy Deal
Website
G-CSF
Company
Interferon alpha, beta , EPO, FSH, G-CSF, Subsidiary in Ireland
Reliance Life Sciences Website
r-hCG , tPA Focus on EU market
Company
Lupin Releasing 2 by end of year - Website
Company
Wosulin(Market)
Wockhardt Early Enterant in Biosimilars Website
10 in Piipeline
Company
Heavy acquisition in China and
Cipla Developing Website
Malaysia
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
