On 16 October 2026, Genentech and Novartis commenced BPCIA proceedings in the US District Court for the District of Delaware against Amneal Pharmaceuticals and its subsidiary, Kashiv BioSciences, relating to Kashiv’s efforts to bring an omalizumab biosimilar to the US market.
Genentech and Novartis are alleging infringement of 9 US patents relating to antibody manufacturing processes, cell culture media, protein production methods, and the use of anti-IgE antibodies for the treatment of food allergies (12,371,728, 12,371,510, 8,574,869, 11,078,294, 11,987,637, 8,986,957, 9,243,224, 12,030,959 and 12,492,265).
The dispute centres on ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), which was developed by Kashiv and licensed to Amneal for exclusive commercialisation in the US. Amneal announced the submission of its Biologics License Application (BLA) for ADL-018 to the FDA on 26 September 2025, paving the way for regulatory review of the product.
In May 2026, Amneal and Kashiv filed an inter partes review (IPR) petition challenging the validity of US Patent No. 12,030,959, one of the patents in suit in the BPCIA proceedings, which relates to methods of treating food allergies in paediatric patients using omalizumab. The petition argues that the claimed methods lack novelty and/or are obvious in light of prior clinical trial publications.
Kashiv has entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025. In September 2026, Alvotech/Advanz Pharma’s Adcomfo® (AVT23/ADL-018) was recommended by the CHMP for approval in 75 mg, 150 mg and 300 mg solution for injection in a pre-filled syringe (PFS) or pre-filled pen (PFP).
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was launched in the US in October 2026 (approved March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and December 2025 (300mg formulation)). Celltrion completed its launch of Omlyclo® (75mg and 150mg) in major European countries, including Germany, Spain, the UK and France, in November 2025 and launched the high dose formulation in Europe in August 2026. In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.
Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026. Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.