Biosimilar Naming: FDA Asked Celltrion For Two Kinds Of Suffixes
Executive Summary
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.
You may also be interested in...
Drug Review Profiles: Behind The Scenes At US FDA
A year in our long-running series of deep dives into FDA review documents.
Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles
First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.
Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles
First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.