AbbVie (NYSE:ABBV) has announced that it has resolved U.S. litigation related to Humira (adalimumab) involving Alvotech Holdings (Reykjavik, Iceland).
The two companies have reached an agreement that will give Alvotech a non-exclusive license to AbbVie’s Humira-related patents in the U.S. starting July 1, 2023.
Under the terms of the agreement, Alvotech will pay royalties to AbbVie to license Humira patents.
In 2020, Alvotech announced that the FDA was reviewing a biologics license application related to a proposed Humira biosimilar known as AVT02. In September 2021, FDA announced that it had delayed its review of the biosimilar candidate.
On February 28, Alvotech announced that FDA had accepted Alvotech’s biologic licensing application (BLA) for ATV02 with new data supporting interchangeability between ATV02 and Humira.
“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert We…