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

Abrilada May Launch From Late 2023 Under A Settlement With AbbVie

Executive Summary

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 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.

Pfizer Makes Plans For Interchangeable Adalimumab Filing

Pfizer has announced plans to file for an interchangeable biosimilar version of adalimumab in the US, ahead of its expected launch of its already-approved Humira biosimilar Abrilada (adalimumab-afzb) in July 2023. The company saw a jump of 36% in its biosimilars segment in Q3 on the back of recent launches. 

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