On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic idiopathic urticaria. Omlyclo® is the first omalizumab biosimilar approved in the UK.
Omlyclo® was also the first omalizumab biosimilar approved in Europe, in May 2024, and in South Korea, in June 2024. Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.
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®.
Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.