Wed Sep 25 09:00:00 UTC 2024: ## Alvotech Initiates Patient Study for Biosimilar to Entyvio® for Ulcerative Colitis

**REYKJAVIK, Iceland – September 25, 2024** – Alvotech, a global biotech company specializing in biosimilar medicines, announced today the start of a confirmatory patient study for AVT16, its biosimilar candidate to Entyvio® (vedolizumab). This study will assess the efficacy, safety, and immunogenicity of AVT16 compared to Entyvio in patients with moderate to severe Ulcerative Colitis.

AVT16 is one of only two biosimilar candidates to Entyvio currently undergoing global confirmatory patient studies. Entyvio is a widely used treatment for Ulcerative Colitis, a disease causing inflammation and ulcers in the bowel lining. In the past year, global net revenues from Entyvio sales reached approximately US$5.4 billion.

“We are excited to initiate this important study for AVT16,” said Joseph McClellan, Chief Science Officer of Alvotech. “This marks another significant milestone in our growing pipeline and portfolio of biosimilars. Alvotech is committed to increasing global access to cost-effective biologic medicines and improving patient lives.”

The multicenter AVT16-GL-C01 study will employ a double-blind parallel design with two groups of participants. Patients will receive either AVT16 or Entyvio, and their progress will be monitored using a standardized score for Ulcerative Colitis disease activity.

Alvotech currently has a portfolio of biosimilars targeting various diseases, including autoimmune disorders, eye diseases, bone disease, respiratory diseases, and cancer. Two of its biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and marketed globally. The company anticipates submitting marketing applications for three additional biosimilar candidates in 2024.

Alvotech’s commitment to developing and manufacturing biosimilars is driven by the company’s mission to provide patients worldwide with high-quality, affordable access to essential medicines.

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