On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial is “a randomized, double-blind, multicenter study designed to demonstrate equivalent efficacy and to compare safety and immunogenicity between AVT04 and STELARA® in patients with moderate to severe chronic plaque-type psoriasis,” and that the trial met its primary endpoint, with results demonstrating therapeutic equivalence between AVT04 and STELARA® and no clinically meaningful differences in safety observed through week 28. Earlier this month, we reported that Alvotech had announced positive top-line results from a pharmacokinetic (PK) study for AVT04. In its latest announcement, Robert Wessman, Alvotech’s Founder and Chairman, stated, “The progress of our proposed biosimilar to STELARA® highlights the advantage of our global, vertically integrated platform. Completing this clinical milestone, less than one year since we recruited the first subject, truly demonstrates the success of our clinical development and integrated approach to rapidly advancing multiple high-quality biosimilar candidates.”

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