Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Biologics Market: Background and Status
- Origins and Progress of the Industry
- Key Biologic Brands
- Existing Regulatory Pathways for Biologics
- U.S. Biologic Regulation: An Evolving and Complicated History
- European Biologic Regulation: the EMEA' s Centralized Procedure
- Stumbling Blocks for Biogenerics
- Biologics: Is the Process the Product?
- For Some Products, U.S. Generics Manufacturers Point to 505(b)(2)
- For BLA-Regulated Products, Nowhere to Start
- Biogenerics Finally Crash the Party
- The EMEA Gives the Green Light to the First Biogenerics
- Omnitrope Fights Its Way to the U.S. Market
- Proactive Legislation in the United States and Europe
- United States-At Least a Beginning
- Implications of Omnitrope' s Approval
- Access to Life-Saving Medicine Act
- Europe-A More Concrete Approach
- Remaining Challenges
- A Look at Select Commercial Contenders
- Biologics Companies
- Biogenerics Companies
- Sandoz
- Teva Pharmaceuticals
- Pliva (Barr Pharmaceuticals)
- Dr. Reddy' s Labs
- Wockhardt
- BiogeneriX (Ratiopharm)
- Stada Biogenerics
- BioPartners
- Cangene
- Dragon Pharmaceuticals
- GeneMedix
- Momenta Pharmaceuticals
- Phage Biotechnology
- Prolong Pharmaceuticals
- ScinoPharm Biotech
- Shantha Biotech
Tables
- 1. Patent and Exclusivity Expiries of Key Biologics
- 2. EMEA' s Adopted Biosimilar Guidelines as of November 2006
- 3. EMEA' s Working Concept Papers for Biogenerics Approvals as of November
2006
- 4. Key Challenges for Biogenerics Manufacturers
Figures
- 1. U.S. Biotech Industry Sales Growth, 1994-2004
- 2. Timeline of Biogenerics Commercialization Milestones
- 3. Top Biotech Companies: Annual Company-Reported Net Sates Revenues,
2000-2005
- 4. Business Strategies for Tapping the Biologics Market with Biogenerics
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