FDA accepts for review Pfizer’s supplemental application for Abrilada (adalimumab-afzb) interchangeability

Pfizer

25 February 2022 - Pfizer today announced that the U.S. FDA has accepted for review the prior approval supplement to the Biologics License Application for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). 

The Biosimilar User Fee Act goal date for an FDA decision is in Q4, 2022.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier