Pfizer’s FDA-Approved Adalimumab Faces Four-Year Wait
Abrilada May Launch From Late 2023 Under A Settlement With AbbVie
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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Provisionally Interchangeable? FDA Weighs ‘Requirements’ For Pfizer’s Adalimumab
Pfizer has responded to Generics Bulletin’s queries regarding its bid to win an interchangeability designation for its Abrilada (adalimumab-afzb) biosimilar to AbbVie’s Humira reference product.
Pfizer Anticipates ‘Fair’ Share Of Adalimumab Market In US
Pfizer expects to make significant strides in the adalimumab market once it launches its Humira biosimilar late next year, but may not be able to enjoy its anticipated interchangeability designation until 2024.
FDA To Review Pfizer’s Abrilada For Humira Interchangeability
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.