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FDA Releases Draft Guidance on Biosimilars

Jonathan Larsen, MPP, Program Coordinator

On February 9, 2012, the US Food and Drug Administration (FDA) released its draft guidance on the development of biosimilars (drugs that are similar to existing "reference" biologic products) in the form of three separate guidance documents, "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product," "Scientific Considerations in Demonstrating Similarity to a Reference Product," and "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009."

In the draft guidance, the FDA sets out its current thinking on studies to determine biosimilarity, including but not limited to, comparative physiochemical and functional studies and animal and clinical studies for any application under the abbreviated approval pathway for biosimilars. The FDA reserves the right to waive the animal and clinical studies depending on other supplied data and the complexity of the protein. The guidance also suggests that the FDA will follow a holistic approach to analyze biosimilar applications. The FDA will make recommendations regarding post-marketing safety studies of biosimilars, what non-US data may be allowable to demonstrate biosimilarity, as well as what "reference" biologic's clinical data may be considered in the development of biosimilars. Public comments for all three documents mentioned above are due by April 16, 2012.

At the end of September 2011, in anticipation of FDA guidance on biosimilars, JNCCN published the "NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives," which provides guidance about the challenges health care providers and other key stakeholders face in incorporating biosimilars into oncology practice in the United States. With the release of FDA's draft guidance there is increasing likelihood of biosimilar drugs used for oncology care entering the US market in the future. The NCCN White Paper is based on the recommendations of the NCCN Biosimilars Work Group, composed of multidisciplinary thought leaders from NCCN Member Institutions and other groups, and discussion at the April 2011 NCCN Oncology Policy Summit: Biosimilars – Regulatory, Scientific, and Patient Safety Perspectives.