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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 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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Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.

Amgen Biosimilars Study Predicts Significant Advances

Amgen’s 2021 Biosimilars Trends Report predicts several imminent advancements in the biosimilars space, especially with the expected US launches of biosimilars to Humira in 2023. According to Amgen, the marketplace is poised to see further growth.

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