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FDA To Review Pfizer’s Abrilada For Humira Interchangeability

Adalimumab Biosimilar Is Set For US Launch In July 2023

Executive Summary

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.

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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.

Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown

Alvotech and AbbVie have settled all of their legal disputes over Alvotech’s AVT02 biosimilar rival to Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm’s US entry date provided by the settlement matches that of Boehringer Ingelheim’s interchangeable Cyltezo lower-strength adalimumab biosimilar.

Alvotech Reveals Action Date For Interchangeable Adalimumab BLA

While awaiting news from the FDA for its biosimilar application referencing the higher-concentration formulation of Humira, Alvotech has announced that the FDA has accepted its BLA supporting interchangeability for the AVT02 candidate.

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