ARTICLES BY KATE COOK
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Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?1/16/2020
Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.