Novel Biologics Will Get Suffixes (Or At Least One Did)

US FDA's approval of Ultragenyx's Mepsevii (vestronidase alfa-vjbk) marks first novel biologic with a suffix, but 10 months after release of the naming guidance how – and even how widely – FDA will implement the policy remains uncertain.

the word suffix on cubes

It took 10 months following the release of final guidance, but the US FDA has finally attached a four-letter suffix to the non-proprietary name of a novel biologic with the agency's approval of Ultragenyx Pharmaceutical Inc.'s Mepsevii (vestronidase alfa-vjbk).

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