On 23 May 2024, Celltrion announced that the European Commission has approved its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
Omlyclo® is the first omalizumab biosimilar approved in Europe. No omalizumab biosimilars have been approved to date in the US. This follows the positive opinion adopted by the CHMP of the European Medicines Agency in relation to Omlyclo® on 22 March 2024.
Celltrion is defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.
Celltrion submitted an A-BLA in the US for its omalizumab bioximilar (CT-P39) in March 2024, in Canada in December 2023, and in Korea in June 2023. Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.