On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), seeking all approved reference indications.
The announcement follows Celltrion’s applications for CT-P55 in Canada in May 2026 and Korea in June 2026. Celltrion is also planning a regulatory filing for CT-P55 in the US.
Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025. In February 2026, Celltrion received approval from the EMA to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55. Celltrion expects this will shorten the overall clinical timeline and reduce development expenses for CT-P55.
Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis). In June 2026, CSPC Pharmaceutical announced that China’s National Medical Products Administration (NMPA) had accepted a marketing authorisation application for its Secukinumab Injection.