AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

Regulatory Guidances  •  U.S. FDA News

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product (“Draft Guidance”), which was made publicly available in January 2017.  AAM, previously known as the Generic Pharmaceutical Association, represents “the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry.”  AAM/Biosimilars Council state that they “generally support FDA’s adoption of the ‘totality of the evidence’ standard and ‘stepwise approach’ for making interchangeability determinations,” and “also support FDA’s position that sponsors may extrapolate data and information supporting interchangeability in one condition of use to other conditions of use, if justified.”  However, AAM/Biosimilars Council opposed other aspects of the Draft Guidance, including the draft proposal for sponsors to submit “data and information” showing “interchangeability for all of the RP’s licensed conditions of use even if the sponsor is not seeking licensure for all such conditions of use.”  With respect to demonstrating interchangability, the AAM/Biosimilars Council proposed that FDA “more clearly define the characteristics that FDA will use to determine a product’s complexity.”  AAM/Biosimilars Council’s full comments are available here.

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