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Biosimilars Law Blog

Tag Archives: United States Adopted Name (USAN) Council

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issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability.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, News & Events

FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.”  Described in an accompanying proposed rule, the Agency proposes that the

Posted in Biosimilars vs. Generics

GPhA Petitions FDA Not to Distinguish Biosimilars by Unique Non-Proprietary Names

The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic.  FDA has not articulated a policy for naming of biologics, biosimilars and interchangeable biosimilars, although they asked for input on the topic in the Public Meetings and

Posted in Global Comparisons

Global Dis-Harmonization of Biosimilar Naming and Labeling

The Food and Drug Law Institute held a recent “Dialogue” on the naming and labeling of biosimilars in the U.S. as the Food and Drug Administration (FDA) implements the abbreviated pathway for biosimilars authorized under the Biologics Price Competition and Innovation Act. While the representatives from FDA participated on both panels—naming and labeling, the remainder