Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown

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

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

More from Biosimilars

More from Products