Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars 2012

Key Topics

• The process and requirements for demonstrating biosimilarity
• FDA`s regulation of biosimilars
• Quality Considerations for demonstrating biosimilarity
• The February 2012 FDA Guidance Documents on Biosimilars
• The process of obtaining biosimilar approval
• Safety Consideration for demonstrating biosimilarity

Who should Attend

Managers, Regulatory Affairs Professionals, Scientists, Consultants, State Policy Officials, Research Analysts, Biologic and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Distributors, and Generic Firms, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists, Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries.