Government Strategies Alert: FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development


Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars.  Biosimilar products are biological products shown to be highly similar (biosimilar) to biological products previously approved by FDA (known as reference products).  Section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act, established an abbreviated approval pathway for biosimilar products.  Applications to FDA seeking approval of biosimilar products are known as 351(k) applications.

The draft guidances, which have been eagerly anticipated by biosimilars stakeholders for some time, address both scientific and quality considerations for demonstrating biosimilarity to reference products and also provide information about implementation of the BPCI Act in a Q&A format.  Each guidance is briefly summarized below.

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Scientific Guidance)

According to the Scientific Guidance, “FDA intends to consider the totality of the evidence provided by a sponsor to support a demonstration of biosimilarity, and recommends that sponsors use a stepwise approach in their development of biosimilar products.”  (Scientific Guidance at 2.)  The Guidance first acknowledges the unique complexities of protein products, and addresses the resulting scientific and manufacturing process considerations.  The Guidance then outlines the stepwise approach to demonstrating biosimilarity and explains how FDA will use the totality of the evidence approach to assess that demonstration.

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