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Full analysis, sources & comparables →Amneal Pharmaceuticals has licensed exclusive U.S. commercialization rights to Kashiv BioSciences' proposed omalizumab biosimilar, targeting Genentech and…
Amneal Pharmaceuticals Inc. and Kashiv BioSciences LLC have entered into an exclusive licensing agreement for the U.S. commercialization of a proposed…
Health Canada validated and accepted the market authorization application for ADL-018, a proposed biosimilar to XOLAIR (omalizumab). Annual XOLAIR sales…
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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).
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Amneal Pharmaceuticals Inc. / Kashiv BioSciences LLC (this deal) | 2024 | — | — |
| Amneal Pharmaceuticals Inc. / Kashiv BioSciences LLC | 2026 | $1.1B | — |
| Amgen Inc. / Immunex Corporation | 2002 | $16.0B | 92 |
| PerkinElmer, Inc. / EUROIMMUN Medizinische Labordiagnostika AG | 2017 | $1.3B | 88 |
| Vertex Pharmaceuticals Incorporated / Alpine Immune Sciences | 2024 | $4.9B | 78 |
| Roche Holding AG / Genentech, Inc. (Roche Group) | 2009 | $46.8B | 72 |
| Travere Therapeutics, Inc. / Everest Medicines Limited | 2026 | $1.1B | 72 |
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