UPDATE: FDA releases final guidance for 'Nonproprietary Naming of Biological Products'

Today, the US Food and Drug Administration released the final guidance for industry "Nonproprietary Naming of Biological Products."

This naming convention will facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances when other means to track a specific dispensed product are not readily accessible or available, as described in section IV.A of this guidance.

The guidance describes the FDA’s current 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.