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

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 names of all currently approved and