FDA Releases Draft Guidance To Aid Manufacturers In Developing Insulin Biosimilars

Beginning on March 23, 2020, the FDA will begin to accept aBLAs for biosimilar insulin products referencing previously approved insulin products.  Prior to this date, insulin products have been approved pursuant to New Drug Applications and, thus, insulin generics were not eligible for approval as aBLAs.  The transition period for insulin products from NDAs to BLAs ends on March 23, 2020.  In order to help manufacturers navigate this space, the FDA released its guidance for industry last week entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products“.  Acting FDA Commissioner Brett P. Giroir, M.D. released a statement accompanying the guidance.  There, he explains that the FDA is “aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products. This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products.”  The draft guidance states that comparative clinical immunogenicity studies may not be necessary to obtain approval for a proposed insulin biosimilar, which may lower development costs and shorten approval timelines in this space.

FDA will be accepting comments on the guidance until January 27, 2020.

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