Pharma BD Deal Intelligence
Kashiv BioSciences entered an exclusive licensing agreement with Amneal Pharmaceuticals (announced July 1-2, 2024) granting Amneal U.S. commercialization rights to ADL-018, a proposed biosimilar to Genentech/Novartis's Xolair (omalizumab), an anti-IgE monoclonal antibody. Kashiv retains development and manufacturing; Amneal handles U.S. launch and sales. Xolair is one of the largest branded biologics still without a launched U.S. biosimilar, with annual sales of ~$5.5B globally, ~$4.1B in the U.S. and ~$1.0B in the E.U. for the 12 months ending June 2025 (IQVIA, per Amneal). Since the deal, ADL-018 has materially de-risked: on June 25, 2025 the partners reported positive topline results from a confirmatory efficacy and safety study in chronic idiopathic/spontaneous urticaria (CIU/CSU), meeting primary and secondary endpoints; on September 26, 2025 Amneal/Kashiv submitted a U.S. BLA to the FDA and the EMA accepted the MAA; and on June 2, 2026 Health Canada validated and accepted the market authorization application. Amneal has guided to a Xolair biosimilar launch within its 2026-2027 biosimilar wave, pending FDA approval. The licensing agreement remains in effect; the product is not yet approved or launched (deal status Pending).