Nonproprietary Naming of Biological Products: Update Guidance for Industry March 2019

Not for implementation. Contains non-binding recommendations.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products: Update.” This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, “Nonproprietary Naming of Biological Products,” dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, “Nonproprietary Naming of Biological Products,” to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, “Nonproprietary Naming of Biological Products,” dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.

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All written comments should be identified with this document's docket number: FDA-2013-D-1543.