Toward a Biogenerics Market: The Regulatory Conundrum

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