Meeting the Challenges of Manufacturing Biosimilars

Introduction

Branded biologics have, until recently, been immune to generics competition; however, the approval of biosimilars in Europe heralds a changing landscape. Legislation enabling the approval of biosimilars is stalled in the U.S. Congress but could pass in 2009, and President-elect Obama supports establishing a biosimilars regulatory framework. Complex manufacturing issues pose some of the most signifi cant challenges to companies seeking to compete in this potentially lucrative market.

Get the Answers You Need to Shape Your Strategy

• Generic versions of off-patent biologics, known as biosimilars, have recently entered European markets. What biosimilar products have been approved in Europe? What will be required to bring biosimilars to market in the United States?
• A major barrier to the development of biosimilar drugs is the diffi culty of manufacturing biologics that are comparable to the original branded product. What are the key issues in ensuring protein drug comparability? What impact do changes in manufacturing processes have on biopharmaceutical products? Can analytic tools used for comparability assessment at innovator companies be applied to biosimilars manufacturing?
• Second-generation biopharmaceuticals are drugs that differ from the original products in formulation or method of delivery. What are the strategic advantages of second-generation biopharmaceuticals? What companies have proprietary technology for creating second-generation pharmaceuticals?
• The entrance of biosimilars in the U.S. market will provide opportunities to many players. Which companies are best positioned to compete in the biosimilars market? Which companies have proprietary technology to support biosimilars development and manufacturing?

• The regulatory and legislative landscape: Europe, the EMEA, the United States, the FDA.
• Manufacturing issues: the production process, glycosylation, determining comparability, comparability assessment analytics.
• Second-generation biopharmaceuticals: approval process, Aranesp, defensive strategy.
• Companies marketing biosimilars: generics manufacturers, specialty companies, Indian generics companies.
• Participation of Big Biotech and Big Pharma: opportunity versus threat, capabilities, pharmaceutical company interest and involvement.
• Technology companies: biosimilar analytics companies, second-generation biopharmaceuticals technologies, alternative manufacturing technology, collaborations, acquisitions.