Drug Review Profile: Inflectra sponsor submitted nonproprietary name suffixes that were both devoid of meaning and meaningful; agency concluded nonmeaningful suffix "-dyyb" was unlikely to be source of error.
With its naming policy in flux, FDA allowed Celltrion Inc. to hedge its bets and propose suffixes that were both meaningful and devoid of meaning for the nonproprietary name of Inflectra (infliximab-dyyb), its biosimilar to Janssen Biotech Inc.'s Remicade (infliximab).
The timing of an FDA draft guidance created some uncertainty for Celltrion as to how it should approach a nonproprietary...
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