Business
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
REYKJAVIK, Iceland and PISCATAWAY, N.J. and LONDON, June 25, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the
About this update from Alvotech
[{"type":"text","content":"REYKJAVIK, Iceland and PISCATAWAY, N.J. and LONDON, June 25, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), 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 (CSU), 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 (ISS7) at Week 12 between the treatment groups of ADL-018 and reference product. “The positive results from this confirmatory patient study represent an important step in the development of the Xolair® biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of Releuko® and Fylnetra®. We look forward to collaborating with regulatory authorities to make this treatment available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, “We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Alvotech and Advanz Pharma.” “The s...