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Biosimilars Law Blog

Monthly Archives: October 2014

Posted in Biosimilar Definitions

FDA Issues Draft Guidances on Reference Product Exclusivity for Biological Products and Clinical Pharmacology for Biosimilars

As biosimilar applications begin rolling in, FDA has issued two of its 2014 “promised” guidances, addressing important issues of how the agency is implementing the BPCIA: (1) what information FDA will consider to determine “first licensure” for a biologic licensed under 351(a), which is essentially a decision on eligibility for the 12-year exclusivity period provided to new biologics; and (2) regulatory expectations for clinical pharmacology in support of a biosimilar application.