Alvotech Moves Forward With Confirmatory Study For AVT16, A Potential Entyvio® Rival

Alvotech, a leading global biotech firm known for its expertise in biosimilar medicine development and manufacturing, has announced the launch of a confirmatory clinical trial for AVT16, its biosimilar candidate to Entyvio® (vedolizumab). This study aims to assess and compare the efficacy, safety, and immunogenicity of AVT16 against Entyvio in a diverse group of participants aged 18 to 80 with moderate to severe active Ulcerative Colitis. Notably, Alvotech is one of only two companies undertaking such a global or multi-country confirmatory study for a biosimilar to Entyvio.

Entyvio (vedolizumab) is used to treat adults with moderate to severe Ulcerative Colitis, which results in inflammation and ulcers in the bowel lining, as well as moderate to severe Crohn’s disease, which causes inflammation in the digestive tract. Over the past year, up to June 30, 2024, Entyvio generated approximately $5.4 billion in global net revenue.

The AVT16-GL-C01 study is designed as a double-blind, parallel-group trial with two arms. Participants will either receive AVT16 or Entyvio, with both groups monitored to assess treatment effectiveness using a standardised Ulcerative Colitis disease activity score. Alvotech’s biosimilars currently address a range of conditions, including autoimmune diseases, eye disorders, bone diseases, respiratory issues, and cancer.

Two of their biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and available in several international markets. Alvotech plans to submit marketing applications for three additional biosimilar candidates in 2024. AVT16 is one of six biosimilar programs still in earlier stages of development.

Joseph McClellan, Chief Science Officer of Alvotech, said in a statement “We are proud to be able to initiate the confirmatory patient study for AVT16, adding another important biosimilar candidate in clinical development to our pipeline. Alvotech’s growing pipeline and portfolio of marketed biosimilars, leveraging our dedicated comprehensive R&D and manufacturing platform, demonstrates our commitment to improving people’s lives globally by increasing access to cost-effective biologic medicines.”