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BIO Comments on FDA Draft Guidance on Nonproprietary Naming of Biological Products: Update

May 3, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Nonproprietary Naming of Biological Products: Update.

BIO is committed to improving access to safe, effective, and affordable therapeutic choices, including biosimilars, which require policies distinct from policies for generic small molecule drugs. As more biosimilars and interchangeable biosimilars become available in the United States, it’s critically important to be able to accurately identify these products.

In the comments, BIO explains the importance of distinguishable, nonproprietary names and a nonproprietary naming convention for biologics. BIO was pleased FDA included the use of a four-letter distinguishable suffix for biologics. BIO provides additional input on a potential naming convention as well as whether vaccines should be included in the scope.

Download Full Comments Below
FINAL BIO Comment Nonproprietary Naming 5-3-19
Please see below to read full comment letter
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