On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US Patent No. 12,030,959. The patent relates to methods for treating food allergies in paediatric patients by administering omalizumab.
Amneal and Kashiv argue that the claims of the US959 patent are invalid because they lack novelty and/or are obvious, including in light of articles disclosing the results of phase 1 or 2 clinical trials of omalizumab in patients with food allergies.
Amneal submitted a Biologics Licence Application (BLA) to the FDA for its omalizumab (ADL-018), biosimilar to Genentech/Novartis’ Xolair®, in September 2025. ADL-018 was developed by Kashiv, with Amneal holding exclusive US commercialisation rights for the product, under a July 2024 licensing agreement.
Kashiv has also 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). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation). Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.
Omalizumab biosimilars are in development, including by Teva (acceptance of regulatory applications for review by the FDA and EMA announced March 2026) and CuraTeQ (phase 3 biosimilar omalizumab trial completed April 2026).