Amgen Seeks Clarity on Whether Biologics' Suffixes Could Cause Misbranding or Adulteration Issues

Regulatory NewsRegulatory News | 27 March 2018 |  By 

Amgen is raising questions about whether the addition of suffixes to nonproprietary names of biologics and biosimilars could cause the products to be deemed by the US Food and Drug Administration (FDA) to be misbranded or adulterated because they do not adhere to the appropriate USP monographs.

Although the FDA draft guidance published in January on labeling regulations does not reference the use of suffixes, Amgen said in comments posted to the docket on Monday that it agreed with FDA’s previous opinion (made in response to a citizen petition from Sandoz, J&J and AAM) that a USP monograph title that consists solely of a core name without a suffix is not applicable to biologics that have nonproprietary names that include a suffix.

But the California-based drugmaker also called on FDA “to make this position explicit in the final guidance” to “help reduce confusion around whether an FDA-approved biologic with a nonproprietary name that includes a suffix might be deemed adulterated or misbranded simply due to failure to comply with a USP monograph identified by core name.”

Amgen cited a letter from Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, that notes how in certain cases, USP has published monographs for biologics.

“A biological product is ‘an article recognized’ in an official compendium only if its proper name matches the official title of a monograph, and it otherwise meets the identity and definition set forth in the monograph,” Woodcock and Marks wrote. “Thus, at the time FDA is licensing a biological product, under FDA's interpretation of section 502(e), such a monograph would apply to the newly licensed biological product only if FDA designates a proper name in the license for the biological product that matches the official title of the relevant USP monograph, and the biological product otherwise meets the identity and definition set forth in that monograph.”

USP told Focus that it has recently released guidance specific to this issue, noting: "For a biologic product licensed under the Public Health Service Act, the official title shall be the title specified in the relevant monograph plus any suffix designated by FDA ...  As FDA implements its naming convention set forth in the Final Guidance, the revision to Section 2.20 of the General Notices is intended to ensure consistency between USP and FDA in the naming of biological products licensed under the PHS Act (biological products). This revision will help address any potential compliance issues by ensuring that a biologic product that is given an FDA-designated suffix is not out of compliance with an applicable USP monograph. At the same time, the additional language provides flexibility, making it possible to apply different compendial approaches in situations where products share the same core name but have different suffixes."

The clarity sought by Amgen is the latest in a host of questions around the use of such suffixes, which only the US is using. Previously, FDA said it would use suffixes in the nonproprietary names for biologics and biosimilars, though the suffixes were only used in biosimilars’ names until recently.

Amgen Comment


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