On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcutaneous use. The approval covers all US indications of Xolair®, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.
Omlyclo® was the first omalizumab biosimilar to be approved in Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).
On 30 January 2025, the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) was valid and infringed by Celltrion. The UK Court judgment followed a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.
Disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague), and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023. In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid. The oral proceedings in the opposition are due to take place in April 2025.
Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark have previously been reported to have omalizumab biosimilars under development.