Alvotech, Kashiv, Advanz announce study of AVT23 met primary endpoint

Alvotech (ALVO), Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study comparing AVT23, a proposed biosimilar to Xolair, with the reference biologic. The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair in patients with Chronic Spontaneous Urticaria, who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score at Week 12 between the treatment groups of ADL-018 and reference product.