[author: Joseph Molinari]
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. The study met both primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to the reference product.
ADL-018, developed in partnership with Alvotech, is expected to be filed with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) later this year. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated the marketing authorization application (MAA). If approved, ADL-018 would join Kashiv’s growing biosimilar portfolio, which includes RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk).
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