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Biosimilars Law Blog
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 Dockets surrounding the issuance of the Draft Biosimilar Guidances.

At the heart of the discussion is whether it is in the best interest of public health and the individual patient for one biologic product to be distinguishable from another based upon the non-proprietary name (often called the “generic” name).  The BPCIA is silent on naming, but FDA retains naming authority under the Food Drug and Cosmetic Act [502(e); 21 CFR Part 299].  The arguments for and against unique names for biologics, including biosimilars, have been articulated through the FDA public process.  The September 17, 2013 GPhA Citizen Petition does not raise anything new.  However, the petition does create a forum for public input and sets the stage for an FDA response on a biologics naming policy.  Docket FDA-2013-P-1153 is open for public comment.