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Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics

 
• By Michael Cipriano

New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.

the word suffix on cubes

In a major policy reversal, the US FDA no longer intends to change the nonproprietary names of innovator biological products that were initially approved without an arbitrary four-letter suffix, a move that may have sweeping implications for the industry.

The move was announced in a March 7 draft guidance, in which the agency said it will continue to attach distinguishable suffixes to the proper names of newly approved biologics and biosimilars

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