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
Tag Archives: international non-proprietary names
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