September 21, 2017
Authored and Edited by Bonnie Fletcher Price, Ph.D.; Thomas L. Irving
On September 21, 2017, FDA released a nonbinding draft Guidance for Industry, Statistical Approaches to Evaluate Analytical Similarity, for comment purposes. The objective of this Guidance is to “assist sponsors in demonstrating, through an evaluation of the analytical similarity of the proposed biosimilar and reference product, that the proposed biosimilar and reference product are highly similar to support licensure under section 351(k) of the PHS Act.” The Guidance describes “the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.”
The agency recommends a three-step, risk-based approach in analytically identifying and assessing important quality attributes of proposed biosimilar products. The first recommended step is a “determination of the quality attributes that characterize the reference product in terms of its structural/physiochemical and functional properties.” The identified quality attributes are then ranked “according to their risk of potential clinical impact.” Finally, the “attributes/assays are evaluated according to one of three tiers of statistical approaches” which are assigned based on consideration of risk ranking and other relevant factors.
Comments on this draft Guidance are due by November 21, 2017—60 days from the date of the proposed Guidance’s publication in the Federal Register.
Read a more in-depth analysis of the FDA’s draft guidance.
Notice of the Guidance can be found at: 82 Fed. Reg. 44425 (Sept. 22, 2017)
abbreviated biologic license application (aBLA), Biologic License Application (BLA), Biologics Price Competition and Innovation Act (BPCIA), FDA Guidance, Food and Drug Administration (FDA)
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