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Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’

 
• By Sue Sutter

Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.

FDA’s final guidance on nonproprietary naming gives biosimilar developers and innovative biologic product sponsors more clarity on how four-letter suffixes will be evaluated for distinguishable nonproprietary names, but it also leaves a wake of questions about how the agency will implement this policy across a large swath of approved products.

The agency is sticking with its plan to require that distinguishable suffixes devoid of meaning be added to the nonproprietary...

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