Pharma BD Deal Intelligence
Amneal's 2024 licensing grab for Kashiv's ADL-018, a Xolair biosimilar, targeted a franchise still lacking any launched U.S. biosimilar and worth roughly $4.1B in the U.S. alone—de-risked fast, with positive CIU/CSU topline data by June 2025, though the BLA submission that September left approval still pending.
Outcome grade pending — assessed 5 years post-close.
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).
5M US cases/yr · $4.6B Xolair 2023 combined global sales (Genentech/Novartis), benchmark for omalizumab biosimilar opportunity · ~30-70% Typical ASP erosion in originator biologic 2-3 years post-biosimilar entry (Humira/adalimumab precedent)
Omalizumab (Xolair) is approved across multiple IgE-mediated conditions: moderate-to-severe persistent allergic asthma (~5 million US adults with allergic asthma eligible for step-up biologics), chronic spontaneous urticaria (CSU, ~1.5-3 million US adults with ~40-50% H1-antihistamine-refractory), chronic rhinosinusitis with nasal polyps (CRSwNP, ~2 million US adults with symptomatic nasal polyps), and IgE-mediated food allergy (FDA-approved February 2024 based on OUtMATCH, expanding the addressable population). Standard-of-care in allergic asthma includes inhaled corticosteroid/LABA combinations with step-up to biologics (anti-IgE, anti-IL-5, anti-IL-4Ra, anti-TSLP). Xolair pioneered the anti-IgE mechanism, sequestering free IgE and preventing high-affinity FcepsilonRI engagement on mast cells and basophils. Xolair generated approximately $3.7-4.6B in global sales in 2023 (combined Genentech US and Novartis ex-US), with US revenue representing roughly 60% of the franchise. Composition-of-matter patents expired in 2019, opening the pathway for biosimilar entry. Biosimilar competition in biologics has historically driven 30-70% ASP erosion within 2-3 years of launch (anti-TNF Humira biosimilar precedent), creating meaningful savings opportunity for Medicare Part B and commercial payers.
The omalizumab biosimilar competitive field targets Xolair's multi-indication franchise. Celltrion's omlyclo (CT-P39) received EMA approval May 2024 and FDA acceptance for review 2024. Teva/Alvotech's AVT23 is in Phase 3. Other announced omalizumab biosimilar programs include Biocon Biologics, Hetero, and Prestige BioPharma. Beyond biosimilars, the originator-competing severe-asthma/CSU biologic landscape includes Sanofi/Regeneron's Dupixent (dupilumab, anti-IL-4Ra, $13B+ 2024 sales, approved CSU April 2025), GSK's Nucala (mepolizumab, anti-IL-5), AstraZeneca's Fasenra (benralizumab, anti-IL-5Ra) and Tezspire (tezepelumab, anti-TSLP, with Amgen). Emerging CSU/asthma entrants include Celldex barzolvolimab (anti-KIT, Phase 3 CSU), Novartis remibrutinib (BTK, Phase 3), Sanofi/Blueprint rilzabrutinib (BTK, Phase 3), and Amgen/AstraZeneca rocatinlimab (OX40, atopic dermatitis extensions). Kashiv/Amneal's ADL-018 positioning relies on US commercialization reach via Amneal's established injectables platform, price-competitive entry into the ~$2.8B US Xolair franchise, and potential interchangeability designation under BPCIA.
Amneal/Kashiv reported the confirmatory efficacy and safety study in chronic idiopathic/spontaneous urticaria (CIU/CSU) met its primary and secondary endpoints, establishing therapeutic equivalence and comparable safety vs. XOLAIR.
Amneal/Kashiv submitted a Biologics License Application to the U.S. FDA for the omalizumab biosimilar candidate, and the EMA accepted the Marketing Authorization Application. Amneal guided to a XOLAIR biosimilar launch within its 2026-2027 wave.
Health Canada validated and accepted the market authorization application for ADL-018, extending the regulatory footprint of the omalizumab biosimilar beyond the U.S. (FDA) and E.U. (EMA).
| 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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