Pfizer’s FDA-Approved Adalimumab Faces Four-Year Wait

Abrilada May Launch From Late 2023 Under A Settlement With AbbVie

 
• By David Wallace
  
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Pfizer has secured FDA approval for its adalimumab biosimilar under the name Abrilada, representing the agency’s 25th biosimilar approval overall. However, patent settlements around the Humira brand mean that Pfizer is not due to enter the market for four years.

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Pfizer has received an FDA nod for its Abrilada adalimumab biosimilar • Source: Shutterstock

Announcing the US Food and Drug Administration’s approval for Pfizer’s Abrilada (adalimumab-afzb) biosimilar, the acting director of the Office of Therapeutic Biologics and Biosimilars within the agency’s Center for Drug Evaluation and Research, Sarah Yim, celebrated the agency’s 25th biosimilar approval and noted that Abrilada was “one of nine new biosimilar products the FDA has taken action on in 2019.”

However, Yim neglected to mention that the intellectual property landscape around AbbVie’s Humira reference brand – and the various...

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