Alvotech Begins Confirmatory Study for AVT16, a Proposed Entyvio® Biosimilar

On September 25, 2024, Alvotech, a global biotechnology firm specializing in biosimilar medications, announced the start of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). This study aims to compare the efficacy, safety, and immunogenicity of AVT16 to Entyvio in adults aged 18-80 with moderate to severe Ulcerative Colitis. Alvotech is notably one of just two companies to have initiated a global or multi-country study for a biosimilar to Entyvio.

Entyvio (vedolizumab) is used to treat moderate to severe Ulcerative Colitis, which causes inflammation and ulcers in the bowel lining, and Crohn’s disease, which causes inflammation of the digestive tract. Over the 12 months leading up to June 30, 2024, Entyvio generated global sales of approximately $5.4 billion.

Joseph McClellan, Alvotech's Chief Science Officer, expressed pride in initiating the AVT16 study, noting that it adds another significant biosimilar candidate to their robust pipeline. McClellan highlighted the company’s dedication to global health through the provision of cost-effective biological medicines.

The AVT16-GL-C01 study employs a double-blind, parallel design with two groups. Participants will receive either AVT16 or Entyvio, and efficacy will be measured using a standardized score for Ulcerative Colitis disease activity.

Alvotech’s portfolio targets a range of conditions, including autoimmune diseases, eye disorders, bone diseases, respiratory diseases, and cancer. The company already markets biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) in multiple global markets. Alvotech plans to submit marketing applications for three additional biosimilar candidates in 2024. AVT16 is one of six biosimilar programs currently in earlier development stages.

AVT16 is a human monoclonal antibody that mirrors Entyvio® (vedolizumab). Vedolizumab targets and binds to the alpha-4-beta-7 protein, predominantly found on T helper lymphocytes. These lymphocytes migrate to the gastrointestinal tract and contribute to the inflammation seen in Ulcerative Colitis and Crohn’s disease. While AVT16 is still an investigational product and has not yet received regulatory approval, its potential impact on treatment options is significant.

In addition to AVT16, Alvotech has developed AVT02, a biosimilar to Humira® (adalimumab), which is approved in over 50 countries, including the U.S., Europe, Canada, and Australia. AVT04, a biosimilar to Stelara® (ustekinumab), is also approved in several regions, including Canada, the European Economic Area, Japan, and the U.S.

Founded by Robert Wessman, Alvotech focuses on developing and manufacturing biosimilar medicines to improve global health by making high-quality, cost-effective treatments accessible. The company boasts a comprehensive R&D and manufacturing platform and has established a strategic network of commercial partnerships to enhance its global reach. These partnerships span across the United States, Europe, Japan, China, and various regions in Asia, South America, Africa, and the Middle East.

Alvotech’s commercial partners include major pharmaceutical companies such as Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, Advanz Pharma, Dr. Reddy’s, Biogaran, Cipla/Cipla Gulf/Cipla Med Pro, JAMP Pharma Corporation, Yangtze River Pharmaceutical Group, DKSH, YAS Holding LLC, Abdi Ibrahim, Kamada Ltd., Mega Labs, Stein, Libbs, Tuteur, Saval, and Lotus Pharmaceuticals Co., Ltd. Each partnership covers specific products and regions, maximizing Alvotech's global market presence.