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.
Alvotech launches confirmatory study for Entyvio biosimilar
Biocon BIologics unveils new dermatology data at EADV Congress 2024
Nektar Therapeutics showcases rezpegaldesleukin at EADV 2024
UCB and Biogen report positive Phase 3 results for dapirolizumab pegol in SLE
Priovant Therapeutics enrols first patients in brepocitinib CLARITY study
AstraZeneca's Fasenra recommended for EU approval in EGPA
Sareum Holdings secures patent allowance for SDC-1801 in China
Kine Sciences reports first patient dosed in KINE-101 Phase 1b/2a clinical study
Carisma and Moderna expand collaboration
Aisa Pharma receives orphan drug designation from FDA for AISA-021(cilnidipine)