USP Submits Comments to FDA on Biologics Naming Guidance

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USP responds to FDA's draft guidance on the naming of biological products.

USP Submits Comments to FDA on Biologics Naming Guidance

The United States Pharmacopeial Convention (USP) has submitted its

to FDA regarding Draft Guidance, Nonproprietary Naming of Biological Products: Guidance for Industry, which details FDA’s biologic naming proposal. FDA has proposed that all biological products have a nonproprietary name that includes a manufacturer-specific FDA-designated suffix.


 “We understand the naming approach for biologics in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products,” said Jaap Venema, PhD, executive vice-president and chief science officer of USP, in a press release. “At the same time, USP believes it is critically important to maintain a uniform and scientifically-based approach that does not create unintended risks for patients and practitioners, and encourages FDA to consider alternative solutions to reach its goals.”

In their comments, USP states, “the existing scientifically-based nonproprietary naming system for biologics and other drugs has served patients and practitioners well for over a century. The naming approach proposed in the Draft Guidance represents a departure from well-established scientific naming principles and could have unintended negative consequences; and while USP shares FDA’s goal of improving safe medication use, USP encourages FDA to consider alternative solutions to achieve this goal.”   

USP plans on commenting separately to FDA’s Proposed Rule, “Designation of Official Names and Proper Names for Certain Biological Products,” which provides proposed names for six products based on the naming convention outlined in the draft guidance. 

Source: USP