Last Thursday, the U.S. Food and Drug Administration issued draft guidances pursuant to its authority under the Biologics Price Competition and Innovation Act of 2009 (see "FDA Publishes Draft Guidelines for Biosimilar Product Development"). The draft guidances are intended by the agency to implement the follow-on biologic drug pathway mandated by the statute, and are set forth in three separate guidances directed to:
1) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
2) Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
3) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
The first draft guidance, directed to scientific considerations concerning biosimilarity, is "focused" on therapeutic polypeptides and uses a "step-wise," "totality of the evidence" approach." As set forth in detail in the draft guidance, this approach addresses the question of biosimilarity using various analytical method "step-by-step," where the results of one assay are interpreted and used to select additional assays that will provide additional information missing or unclear from earlier assays. The first step is always "rigorous" comparisons of the physicochemical characteristics and functional properties of a candidate biosimilar drug, performed in comparison with the reference drug product. From these results, the draft guidance recommends animal toxicity testing (as expressly required by the statute), human pharmacokinetic and pharmacodynamics studies, immunogenicity studies, and clinical safety and effectiveness trials. The draft guidance also recommends postmarketing safety monitoring for biosimilar products having a reference drug product known to be associated with significant risks of adverse events. This guidance also defines the use of the term "should" as meaning "recommended" rather than "required" by the agency.
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