Toward a Biogenerics Market: The Regulatory Conundrum

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