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Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown

US Launch Date Matches That Of BI’s Cyltezo Interchangeable Humira Biosimilar

 
• By Dave Wallace

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.

Knights Chess Pieces Black White Face Off
Alvotech and Boehringer Ingelheim could launch rival interchangeable Humira biosimilars on the same date • Source: Thomas LENNE / Alamy Stock Photo

A face-off in the US between two different strengths of interchangeable Humira (adalimumab) biosimilars could be on the cards for 1 July 2023, after Alvotech settled all of its legal disputes with originator AbbVie, gaining a launch date that matches that of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) version.

While Cyltezo has already been approved by the US Food and Drug Administration – with the lower-strength 50mg/ml adalimumab biosimilar also granted an interchangeability designation last year (Also see "First Interchangeable Humira Biosimilar Approved In US" - Generics Bulletin, 18 October, 2021

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