Wed Sep 25 09:12:04 UTC 2024: ## Alvotech Initiates Confirmatory Study for Biosimilar to Entyvio®

**REYKJAVIK, ICELAND – September 25, 2024** – Alvotech (NASDAQ: ALVO), a global biotech company specializing in biosimilar medicines, announced the launch of a confirmatory patient study for AVT16, its biosimilar candidate to Entyvio® (vedolizumab). The study aims to confirm the efficacy, safety, and immunogenicity of AVT16 compared to Entyvio in patients with moderate to severe active Ulcerative Colitis.

Alvotech is one of only two companies known to have initiated a global confirmatory study for an Entyvio biosimilar. Entyvio, a drug indicated for moderate to severe Ulcerative Colitis and Crohn’s disease, generated approximately $5.4 billion in global net revenue in the twelve months leading up to June 30, 2024.

“We are proud to initiate this confirmatory study for AVT16, adding another important biosimilar candidate to our growing pipeline,” said Joseph McClellan, Chief Science Officer of Alvotech. “This underscores our commitment to providing patients with access to cost-effective biologic medicines.”

The AVT16-GL-C01 study will be a double-blind, parallel trial involving two groups: one receiving AVT16 and the other receiving Entyvio. The study’s primary endpoint will assess the efficacy of both treatments based on standardized scores for Ulcerative Colitis disease activity.

Alvotech’s biosimilar portfolio already includes two approved and marketed products: a biosimilar to Humira® (adalimumab) and a biosimilar to Stelara® (ustekinumab). The company expects to file marketing applications for three additional biosimilars during 2024.

AVT16 is currently in the early stages of development, with six other biosimilar programs also underway. The company’s existing portfolio targets a range of diseases including autoimmune disorders, eye disorders, bone disease, respiratory disease, and cancer.

Alvotech’s commitment to biosimilar development is driven by its goal of increasing access to affordable biologic medicines and improving the lives of patients worldwide.

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