Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
- Published: April 2011
Biosimilars or FOBs (Follow-on biologics) refer to generic versions of patented branded biological drugs, developed subsequent to the patent expiry of brand name products. The biosimilars market is segmented into peptides, recombinant glycosylated proteins, recombinant non-glycosylated proteins, and others. In 2009, biosimilar recombinant non glycosylated protein products formed the largest market segment since blockbuster biopharmaceutical drug such as interferon, human growth hormone-Somatropin, insulin and G-CSF; belong to this class and have wide range of applications.
Overburdened due to rising healthcare costs, ageing population, expensive drugs and pharmaceutical expenditure, biosimilar market is getting boost from increasing user acceptance and emerging Indian and Chinese markets. The major challenge for the biosimilar market is risk involved with the high investment and possible failure of the drug during development stages. However, opportunities for biosimilar market is immense, as biologics are going to be off patent by 2015 and an anticipated approval pathway in U.S will open up potentially largest market. The growth potential of the biosimilars market is expected
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1. Global Biopharmaceutical Market
2. Global Biosimilars Market
2.1 Overview
2.2 Market Size
2.3 Geographical Segmentation
2.4 Currently Marketed Biosimilars
2.4.1 Erythropoietin
2.4.2 Human Growth Hormone
2.4.3 Filgrastim
3. Market Drivers
3.1 Rising Healthcare Costs
3.2 Large Number of Blockbuster Biologics Slated for Patent Expiry
3.3 Leading Generics Players Spearheading Development
3.4 Rise in Ageing Population
3.5 Cost Effective Option for Pharmaceutical Companies
4. Market Constraints
4.1 Regulatory Restrictions and Hurdles
4.2 High Development Costs 24
4.3 Manufacturing Complexities
5. Opportunities
5.1 Burgeoning Indian and Chinese Market
5.2 Monoclonal Antibodies- Fastest Growing segment
6. Market Outlook
7. Major Players
7.1 Teva Pharmaceuticals Industries Ltd.
7.1.1 Business Description
7.1.2 Business Strategies
7.2 Biocon
7.2.1 Business Description
7.2.2 Business Strategies
7.3 Hospira Inc.
7.3.1 Business Description
7.3.2 Business Strategies
Charts and Figures:
Biopharmaceutical Value Chain
Global Biopharmaceutical Market (2004-2009)
Global Biopharmaceutical Market by Product (2009)
Categories of Biosimilars Market
Biosimilars Development Process
Difference between Small Molecule Generics and Biosimilars
Global Biosimilar Market Revenue (2008-2014F)
Global Biosimilars Market by Product (2009)
Global Market Potential for Biosimilars in Different Categories (2009)
Major Blockbuster biologics whose patents will expire from 2012- 2019
Marketed Biosimilars by Product Group
Total Healthcare Expenditure Per Capita in Selected Developed Countries (2008)
Real Annual Growth in per Capita Health Spending (%): 2000-2008
Potential Market Potential for Biosimilars
Leading Players in Biosimilars market and Products in Pipeline
Ageing Population Worldwide (age>65) 2005-2015F
Cost Comparison of Biosimilars and Innovator Biologics
Biosimilar Approval in EU
Indian Biosimilars Market Revenue (2008-2012F)
India’s Biosimilar Market Breakdown (2009)
Potential Global Market for Biosimilars (2008-2015)
Number of Biologics Scheduled to Go-off Patent (2008-2015)
Annual Revenues of Teva Pharmaceuticals (2005-2009)
Annual Revenues of Biocon (FY06-FY10)
Annual Revenues of Hospira Inc. (2009)
- Teva Pharmaceuticals Industries Ltd
- Biocon
- Hospira Inc.
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