バイオジェネリック薬市場：規制に関する問題点

Abstract

Introduction

The sales that biologic agents command and the costs that they impose for payers combine to generate intense interest in the development of generic biologic agents, or biogenerics. However, the biogenerics market has been very slow to establish itself. The key reason is the lack of a defined regulatory framework and uncertainty-on the part of manufacturers and regulators alike-regarding what biogenerics will look like and how they will reach the market.

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In the spring of 2006, two companies made history by producing the fi rst two approved biogenerics in the European Union. Which two companies were they, and what products were approved? What steps has the European Medicines Agency (EMEA) taken to clarify the path to approval? The biologics that bring in the most sales will be the natural focus of biogeneric development. Which branded biologics are the most popular targets? In late September 2006, Representative Henry Waxman introduced the Access to Life-Saving Medicine Act, which would amend section 351 of the Public Health Service Act. How could this bill foster the development of biogeneric products in the United States? What other actions are interested parties taking? Several generic drug manufacturers have entered or are hoping to enter the biogenerics market. Which companies are they and which biological products are they targeting? What business models are they using?

Scope

• The biologics market: origins and progress.
• The regulatory pathway for biologics: United States and Europe.
• The biogenerics market: origins and progress.
• Current and potential regulatory pathways for biogenerics: United States and Europe.
• Select company profi les: biopharmaceutical companies and biogenerics companies.

Mentioned in This Spectrum Report

Biologic brands

• Aranesp
• Avastin
• Enbrel
• Epogen
• Herceptin
• Humulin
• Intron A
• MabThera
• Neopogen
• Neulasta
• Procrit
• Protropin
• Pulmozyme
• Recombivax
• Remicade
• Rituxan
• Roferon-A

Companies

• Amgen
• Barr Pharmaceuticals
• Berlex
• Biogen Idec
• BiogeneriX
• BioPartners
• Cangene
• Celgene
• Celltech
• Centocor
• Dr. Reddy' s Laboratories
• Dragon Pharmaceuticals
• Eli Lilly
• GeneMedix
• Genentech
• Genzyme
• Johnson & Johnson
• LG Life Sciences
• MedImmune
• Merck
• Momenta Pharmaceuticals
• Ortho Biotech
• Phage Biotechnology
• Pliva
• Prolong Pharmaceuticals
• Ratiopharm
• Roche
• Sandoz
• Schering-Plough
• ScinoPharm Biotech
• Serono
• Shantha Biotech
• Stada Biogenerics
• Takeda
• Tanabe-Seiyaku
• Teva Pharmaceuticals
• Wockhardt
• Wyeth

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