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Biosimilars Law Blog

Tag Archives: Clinical Pharmacology

Posted in Biosimilar labeling, Biosimilars Patent Exchange, News & Events

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the

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.