Amneal Pharmaceuticals (Nasdaq: AMRX) announced positive topline results from a Phase 3 clinical trial for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The study met its primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to XOLAIR® in 400 patients with Chronic Idiopathic/Spontaneous Urticaria.
The trial evaluated doses of 150mg or 300mg administered subcutaneously every four weeks over 24 weeks. Amneal holds exclusive U.S. commercialization rights, with a Biologics License Application (BLA) planned for Q4 2025. The biosimilar targets the $3.9 billion U.S. omalizumab market and is part of Amneal's strategy to launch six biosimilars across eight product presentations by 2027.
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