FDA Releases a draft guidance for industry “Nonproprietary Naming of Biological Products: Update”

Read FDA’s statement on the issuance of the draft guidance for industry “Nonproprietary Naming of Biological Products: Update.”  This draft guidance describes FDA’s current thinking that the nonproprietary names of biological products licensed under section 351 of the Public Health Service Act (PHS Act) without an FDA-designated suffix do not need to be revised to add a suffix to accomplish the objectives of the naming convention described in the final guidance for industry on Nonproprietary Naming of Biological Products (Naming Guidance), issued in January 2017.  

The draft guidance also notes that FDA does not intend to apply the naming convention described in the Naming Guidance to biological products that are the subject of an approved application under section 505 of 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 section 351 of the PHS Act on March 23, 2020 (transition biological products).

The draft guidance also describes FDA’s current thinking on the appropriate suffix format for the proper name of an interchangeable biological product licensed under section 351(k) of the PHS Act.  For each interchangeable product, 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. 

FDA is also reconsidering whether vaccines should be within the scope of the naming convention. 

FDA is not proposing changes to any aspects of the final guidance not included for comment in this draft guidance update. FDA is issuing this draft guidance document to seek public comment on these issues through the accompanying docket.  After reviewing the comments received in the docket, we intend to revise the Naming Guidance and to amend sections, such as sections IV.D and V.B, in that document regarding the subjects addressed in this guidance and issue a revised, final version of the Nonproprietary Naming of Biological Products. 

FDA also released a Manual of Procedures (MAPP), Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act,  to be used in the Center for Drug Evaluation and Research (CDER) for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act. This MAPP describes procedures for handling requests for nonproprietary name suffix review for investigational new drug applications (INDs) and biologics license applications (BLAs) for originator biological products, related biological products, and biosimilar products. Similarly, CBER will issue a Standard Operating Procedure and Policy (SOPP) to be used in CBER for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act.

FDA believes that the core objectives of the naming convention — pharmacovigilance and safe use — can be accomplished by applying the naming convention to biological products at the time they are newly licensed under section 351 of the PHS Act, and without applying it to previously licensed or approved biological products that do not contain a suffix in their proper names.  This approach is intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients.  Furthermore, applying the naming convention to all biological products at the time they are licensed is expected to mitigate the risk of inaccurate perceptions of the relative safety and effectiveness of biological products based on licensure pathway.

For information on the guidance and how to comment, please see the Federal Register Notice