Meeting the Challenges of Manufacturing Biosimilars

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• The Regulatory and Legislative Landscape
  • Europe
  • United States
• Manufacturing Issues
  • The Production Process
  • The Importance of Glycosylation
  • Determining Comparability of Recombinant Protein Drugs
  • Can Comparability Assessment Analytics Support Biosimilars Development and Manufacturing?
• Second-Generation Biopharmaceuticals
• Companies Marketing Biosimilars
  • Sandoz
  • Teva Pharmaceutical
  • BioPartners
  • Ranbaxy
  • Dr. Reddy' s Laboratories
• Will Big Biotechs and Big Pharmas Participate in Biosimilars Manufacturing?
• Select Companies with Technology for Biosimilars and Second-Generation Biopharmaceuticals
  • Momenta Pharmaceuticals
  • Procognia Israel
  • Prolong Pharmaceuticals
  • GlycoFi
  • CoGenesys
• Outlook for Biosimilars
  • About the Author

• The Case of Myozyme

Tables

• 1. Patent Expiry Dates for Key Biologic Brands
• 2. Biosimilar Agents Approved or Authorized in the European Union and United States
• 3. Biosimilars Versus Second-Generation Biopharmaceuticals: Development, Exclusivity, and Pricing
• 4. Select Companies Marketing/Developing Biosimilars/Second-Generation Biopharmaceuticals or Offering Related Technology

Figures

• 1. Top Biologics Brands: Company-Reported Worldwide Sales, 1998-2007
• 2. The 100 Best-Selling Therapies Worldwide, by Technology, 2007
• 3. General Biopharmaceutical Manufacturing Scheme