Biotech company Alvotech S.A. (NASDAQ:ALVO) announced on Wednesday that it has initiated a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio (vedolizumab).

The study aims to demonstrate comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in patients with moderate to severe active ulcerative colitis.

Entyvio is indicated for the treatment of ulcerative colitis and Crohn's disease. With global sales of approximately USD5.4bn in the past 12 months, Entyvio is a significant market opportunity for biosimilars.

The AVT16-GL-C01 multicentre study will compare AVT16 to Entyvio in a double-blind parallel design. Participants will be followed to assess disease activity using a standardised score.

Alvotech's biosimilars portfolio targets various therapeutic areas, including autoimmune diseases, eye disorders, bone disease, respiratory disease and cancer. With two approved biosimilars and three additional candidates in development, Alvotech is expanding its presence in the biosimilars market.