USP Comments on FDA Biologics Naming Draft Guidance

The United States Pharmacopeial Convention (USP) has commented on the FDA draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry”, which describes FDA’s proposal that all biologics bear a nonproprietary name that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“We understand the naming approach for biologics in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products,” said Jaap Venema, Ph.D., executive vice president and chief science officer of USP. “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.”

Throughout its history, USP has helped ensure medicines are of high-quality, safe and effective through its legally-recognized role in setting scientifically-based public standards for identity, purity, quality and strength, as well as packaging and labeling. As part of USP’s legally mandated role, the organization is part of a well-established drug naming system, which includes the naming of biologics.

USP’s comments to the FDA’s draft guidance highlights the following key concepts:

(1) USP has a long history of setting quality standards for biologic drug substances and products;

(2) the existing scientifically-based nonproprietary naming system for biologics and other drugs has served patients and practitioners well for over a century;

(3) the naming approach proposed in the Draft Guidance represents a departure from well-established scientific naming principles and could have unintended negative consequences;

(4) while USP shares FDA’s goal of improving safe medication use, USP encourages FDA to consider alternative solutions to achieve this goal.