USP Comments on FDA's Proposed Naming System for Biosimilars


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 11-03-2015 13:33

  

The United States Pharmacopeial Convention (USP) has submitted its comments on the US Food and Drug Administration’s (FDA) draft guidance, Nonproprietary Naming of Biological Products: Guidance for Industry. The draft guidance describes FDA’s proposal that all biological products bear a nonproprietary name that includes a manufacturer-specific FDA-designated suffix.

USP said it acknowledges FDA’s efforts to advance the successful implementation of the Biologics Price Competition and Innovation Act. “We understand the naming approach for biologics in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products,” said Jaap Venema, executive vice president and chief science officer of USP, in a statement. “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.”

USP says its comment to the FDA’s draft guidance highlights the following concepts: (1) USP has a long history of setting quality standards for biologic drug substances and products; (2) the existing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and other drugs has served patients and practitioners well for over a century; (3) the naming approach proposed in the draft guidance represents a departure from well-established scientific naming principles and could have unintended negative consequences; and (4) while USP shares FDA’s goal of improving safe medication use, the USP said it encourages FDA to consider alternative solutions to achieve this goal.

Along with the draft guidance, the FDA has issued a proposed rule, Designation of Official Names and Proper Names for Certain Biological Products, which sets forth proposed names for six products based on the naming convention outlined in the draft guidance. USP will be commenting separately on the proposed rule.

Source: USP

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