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Biosimilars Law Blog

Category Archives: Biosimilar Definitions

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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.

Posted in Biosimilar Definitions, Global Comparisons

EMA releases a draft revision to the Biosimilars Guideline for public consultation

The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.