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 !!!