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FDA To Review Pfizer’s Abrilada For Humira Interchangeability

Adalimumab Biosimilar Is Set For US Launch In July 2023

 
• By Chloe Kent

The US FDA is reviewing Pfizer’s Humira biosimilar, Abrilada, to assess whether the compound can be granted an interchangeability designation with the original drug.

Signpost two directions
Pfizer is seeking an interchangeable designation for its adalimumab biosimilar • Source: Frannyanne / Alamy Stock Photo

After announcing plans for the filing as it reported its Q3 results last year, Pfizer’s Abrilada (adalimumab-afzb) is now one step closer to being classed as an interchangeable biosimilar with AbbVie’s Humira (adalimumab), following the US Food and Drug Administration’s acceptance for review of the prior approval supplement to the biologics license application for the compound.

The PAS was supported by positive topline data from Pfizer’s REFLECTIONS B538-12 study, which evaluated multiple switches between Abrilada and...

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