Key Issues to Consider When Bringing Biologics to Market in Europe and Japan

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
  • Biologics by the Numbers
  • Scope of This Report
• Key Elements to Consider in Commercializing Biologics in Europe and Japan
  • Regulatory Process
  • Price Setting
• European Perspective on the Biologics Environment
  • Review Times for Novel Therapies
    • Accelerated Assessment
    • Conditional Marketing Authorization
  • Orphan Drug Status
• Japanese Perspective on the Biologics Environment
  • Inadequate Infrastructure for Clinical Development
  • Regulatory Barriers
• How Are Biologics Makers Pursuing the European and Japanese Markets?
  • The European Landscape
  • The Japanese Landscape
• Pricing and Reimbursement of Biologics
  • Europe
  • Japan
    • Similar-Effi cacy Comparison Method
    • Cost-Calculation Method
• Impact of Biosimilars on the Biologics Market
  • Europe
  • Japan
• The Future of Biologics in Europe and Japan

Expert Commentary

• Health Technology Assessment: A Growing Challenge for the Biologics Industry in Europe Neil Grubert, M.A.

Sidebars

• Clinical Requirements Case Study: Why Amevive Failed and Raptiva Succeeded in Gaining Approval
• Pricing Methodology Case Study on Avastin: When Market Size Matters

Tables

• 1. Number of Drug Approvals via the Centralised Procedure, 2005-2008
• 2. Prices of Leading Biologics in Europe and Japan as a Percentage of U.S. Prices, 2006
• 3. Best-Selling Biologics in Japan, 2006-2007
• 4. Select Biologics Collaborations, January 2007-June 2008
• 5. Select Japanese Pharma Companies' Biologics Sales in Proportion to Total Sales,
• 6. Japanese Company Pipelines: Late-Stage Biologics
• 7. Comparative Price and Sales of Key Biologics in Japan (vs. U.S. Prices), 2006
• A. Price of Chugai' s Avastin (Bevacizumab) in Select Major Markets

Figures

• 1. Worldwide Sales of the Top 100 Pharmaceutical Drugs, by Type
• 2. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in Europe and Japan as a Percentage of U.S. Prices
• 3. Biologics as a Proportion of All Drugs Across the Major Markets, by Development Status
• 4. Number of Conventional-Technology Blockbusters vs. Biotechnology Blockbusters, 1997-2007
• 5. Market of First Launch of New Molecular Entities, 2005-2007
• 6. Number of Biologics Approved in Japan, 2005-2007