FDA Releases Updated Guidance on Naming Biological Products

March 7, 2019

Biosimilars Team

The U.S. Food and Drug Administration (FDA) has released an updated draft guidance on the nonproprietary naming of biological products.

Notable changes in the updated guidance include the following:

  • The FDA no longer intends to modify the proper (i.e., nonproprietary) names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names.
  • The FDA does not intend to apply the naming convention to the proper names of transition biological products (i.e., certain biological products such as insulin and human growth hormone that will be removed from the Orange Book and transitioned to the Purple Book).
  • Going forward, for interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.

As FDA Commissioner Scott Gottlieb, MD, acknowledged in an accompanying statement, there has been considerable debate since the biosimilar pathway was established in 2010 regarding how biological products should be named and whether a unique identifier such as a distinguishing suffix should be added to the proper names of biological products to help ensure strong pharmacovigilance. According to Gottlieb, the new framework will aid in adverse event report tracking because originator, biosimilar, and interchangeable products will have nonproprietary names that are distinct from each other. Additionally, under this updated policy, any product that is first licensed as a biosimilar and later determined to be interchangeable will keep its nonproprietary name after receiving a determination of interchangeability.

Electronic or written comments on the draft guidance will be accepted through May 7, 2019. Based on the comments received, the FDA intends to ultimately issue a revised, final version of the 2017 Nonproprietary Naming of Biological Products guidance that amends the relevant sections necessary to incorporate input.