On 9 December 2024, Celltrion announced that Omlyclo® (CT-P39), biosimilar to Genentech/Novartis’ Xolair® (omalizumab) was approved by Health Canada. The approval is for all indications of Xolair®, including allergic asthma, idiopathic urticaria and chronic rhinosinusitis with nasal polyps and follows the submission of Celltrion’s application in December 2023.
Omlyclo® is the first omalizumab biosimilar to be approved in Canada. It was also the first to be approved in Europe (May 2024), South Korea (June 2024), the UK (July 2024) and Australia (November 2024). Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024.
Novartis/Genentech and Celltrion are involved in UPC proceedings regarding alleged infringement of EP3805248 relating to an omalizumab formulation. In September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion.