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 Wessman, founder and chairman of Alvotech, in a press release. “We view today as a key milestone for patients and for our mission to fight for healthcare sustainability.”
Alvotech claims to be the only company with a high-concentration biosimilar candidate to Humira that has conducted a switching study needed for regulatory authorization.
Alvotech is partnering with Teva Pharmaceuticals to potentially commercialize AVT02 in the U.S.
AVT02 has already won approval in Europe, Canada and the U.K.
Filed Under: Biologics