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

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.

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be “highly similar” or “interchangeable” with a reference biological product (e.g., vaccines, antibodies, blood and blood components, gene therapies, tissues, and proteins) that have already been approved or “licensed.”

Areas Covered in the Seminar:

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