The FDA has decided not to require four-letter suffixes for already-approved or licensed biological products with no FDA-designated suffix in their proper names.
The agency issued draft guidance in January 2017 seeking to add a unique four-letter suffix to the proper names — also called “nonproprietary names” — of biological products, including originator products and biological products already on the market. But the proposal drew pushback from drugmakers who expressed concern that adding suffixes to older biologics’ names could confuse patients.
In a draft guidance, the agency explained that it considers it unnecessary to change the proper names of biological products that have already received licensing or approval and that lack an FDA-designated suffix. “The core objectives of the naming convention — pharmacovigilance and safe use — can be accomplished by applying the naming convention to biological products at the time they are licensed … and without applying it to licensed biological products that do not contain a suffix in their proper names,” the agency said.