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Pharmaceuticals / Regulatory Affairs

AAM Rejects FDA’s Updated Biosimilar Naming Policy

May 17, 2019
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The Association for Accessible Medicines (AAM) and its Biosimilars Council is urging the FDA to scrap its proposed suffix-based naming policy for biological products because it would act as “a barrier to biosimilars access.”

The generics and biosimilars group called the FDA’s updated policy “misaligned” with the agency’s August 2018 action plan for biosimilars, which then-Commissioner Scott Gottlieb said would help kickstart a dull, uncompetitive biosimilar market and promote innovation.

AAM said the proposed naming policy “delays and derails the development of biosimilars and is as much of an obstacle for patient access to biosimilars as patent thickets, rebate traps, misinformation campaigns and other anticompetitive tactics used by some brand biologic manufacturers.”

The updated guidance released in March modified the FDA’s original plan to use the naming convention for older biologic and said the agency believes it’s unnecessary to change the names of already approved or licensed biological products that lack an agency-assigned suffix.

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