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Approval Alert: Celltrion’s Omlyclo is First Korean Approved Omalizumab Biosimilar

Jun 25, 2024

On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria.  This is the first omalizumab biosimilar approved in Korea. 

Omlyclo® was also the first omalizumab biosimilar approved in Europe for allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.  Celltrion is currently 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 aBLA in the US for its omalizumab biosimilar (CT-P39) in March 2024 and in Canada in December 2023.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.