FDA To Review Pfizer’s Abrilada For Humira Interchangeability
Adalimumab Biosimilar Is Set For US Launch In July 2023
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 has reported healthy growth of a tenth for its biosimilars portfolio in the first half of 2022, at the same time as its sterile injectables sales slipped by a similar degree.
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 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.