Alvotech Clinical Study Confirms Therapeutic Equivalence for AVT04

Alvotech announced on May 24, 2022, that its biosimilar candidate, AVT04, has successfully met its primary endpoint in a confirmatory clinical study. This indicates therapeutic equivalence between Alvotech's AVT04 and the reference product Stelara® (ustekinumab).

The randomized, double-blind, multicenter study involved 581 patients with moderate to severe chronic plaque psoriasis across four European countries. The study confirmed equivalent efficacy and showed no clinically meaningful differences in safety up to week 28. Alvotech is the second company to report positive top-line results from a patient study for a Stelara® biosimilar candidate.

Stelara®, used to treat inflammatory conditions including psoriasis, Crohn's disease, and ulcerative colitis, generated over $9 billion in worldwide sales in 2021. Ustekinumab is a monoclonal antibody targeting the p40 protein subunit of IL-12 and IL-23 cytokines.

Alvotech is developing a pipeline of biosimilars, including AVT02, a biosimilar to Humira®. The company has established global commercial partnerships, including with Teva Pharmaceuticals for the U.S. market and STADA for Europe, for the commercialization of AVT04.