REYKJAVIK, Iceland– A U.S. federal judge has dismissed a lawsuit brought by AbbVie against Alvotech Hf alleging theft of trade secrets. Alvotech, an Iceland-based biosimilar company, is seeking to bring an affordable high-concentration biosimilar of Humira®(adalimumab) to the market. Judge Harry D. Leinenweber of the U.S. District Court for the Northern District of Illinois, Eastern Division, issued the ruling Wednesday, Oct. 6.
“Alvotech’s mission is to bring affordable medicines to market as soon as we can. Meritless accusations aimed at denying access to affordable medicines will not deter us from our mission and today serves as an affirmation of our efforts,” said Róbert Wessman, founder and chairman of Alvotech.
AbbVie’s lawsuit was another attempt to preserve its monopoly over Humira and prevent Alvotech’s proposed biosimilar from being available to patients in the United States.
Alvotech is the only known company that has both submitted a Biologics License Application (BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT02 in the United States.
Adalimumab inhibits tumor necrosis factor, which is a protein in the body that causes inflammation. Adalimumab is used to treat certain inflammatory conditions. Humira recorded global sales of about US$20 billion in 2020, making it the largest-selling biologic medicine in the world.
On Sept. 10, Alvotech announced positive top-line results for a switching study between its proposed biosimilar AVT02 and Humira. The purpose of the switching study is to support the potential approval of AVT02 by the U.S. Food and Drug Administration as an interchangeable product with Humira.
