Kashiv BioSciences announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab). The randomized, double-blind, multicenter study assessed the efficacy and safety of ADL-018 compared to XOLAIR® (reference product) in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines.
The clinical study achieved its primary and secondary endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR®. 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.
“This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk). 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 including Amneal, Alvotech, and Advanz Pharma.”
“We are pleased with the positive Phase 3 results for ADL-018, which represents an important step towards making a biosimilar to XOLAIR® available to U.S. patients,” said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. “Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to commercialize six biosimilars across eight product presentations by 2027.”
“The positive results from the confirmatory patient study represent an important step in the development of the XOLAIR® biosimilar candidate, and 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.
“The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR® mark an important milestone in Advanz Pharma’s ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia,” said Nick Warwick, Chief Medical Officer at Advanz Pharma.
The Biologics License Application (BLA) for this product is expected to be filed with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for ADL-018 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected in the fourth quarter of 2025.
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