Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars - Webinar By ComplianceOnline

Why Should You Attend:-

On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDA’s proposed abbreviated approval pathway.

This webinar will provide an introduction to FDA’s proposed regulation of biosimilars based on past Agency statements and information contained in its recently published draft Guidance Documents. It is intended to provide an easy-to-understand primer on FDA’s suggested approach for demonstrating biosimilarity between a Reference Biological Product and a proposed copy.

Learning Objectives:-

• Gain a basic understanding of FDA's proposed regulatory approach for allowing the marketing and sale of biosimilars.
• Provide attendees with an overview of the three guidance documents published by FDA earlier this year and highlight important elements of each.
• Describe the process for demonstrating biosimilarity to an identified Reference Biological Product including FDA's proposed “stepwise approach”.
• Discuss the criteria used for showing biosimilarity including a discussion of the analytical factors a company must consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product.