Sandoz raises questions with FDA draft guidance on statistical approaches for biosimilars
Martin Schiestl, chief science officer at Novartis’ Sandoz, on Tuesday explained how the FDA’s draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.
Schiestl told attendees of DIA’s biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, “is typically recommended for quality attributes with the highest risk ranking and should generally include assay(s) that evaluate clinically relevant mechanism(s) of action of the product for each indication for which approval is sought.”
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