REYKJAVIK, Iceland--(BUSINESS WIRE)-- 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.
Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech's shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Robert Wessman, Fuji Pharma from Japan, YAS Holdings form Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, ATHOS (Strüngmann Family Office) from Germany and CVC Capital Partners and Temasek from Singapore through their participation in Alvogen.
Alvotech's initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.
AVT02 is a monoclonal antibody and a proposed biosimilar to Humira (adalimumab). AVT02 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.
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