FDA releases guidance on nonproprietary naming of biologics

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FDA released the final guidance for industry “Nonproprietary Naming of Biological Products.”

The guidance describes the agency’s thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include an FDA-designated suffix.

Under this naming convention, FDA will designate a distinguishing suffix that is devoid of meaning and composed of four lowercase letters in the nonproprietary names for originator biological products, related biological products, and biosimilar products. The suffix will be attached to each product’s core name with a hyphen.

FDA is continuing to consider the appropriate suffix format for interchangeable products.

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