On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency (EMA) to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab). Celltrion expects this approval to shorten the overall clinical timeline and to reduce development expenses for CT-P55.
The Phase 3 trial is designed to evaluate the efficacy, safety and equivalence of CT-P55 in comparison to Consentyx® in patients with plaque psoriasis. The FDA approved the global Phase 3 trial in August 2024. Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.
Other secukinumab biosimilars in development include Bio-Thera’s BAT2306 (Phase 1 trial completed in 2023, Phase 3 clinical trial completed in 2024; commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (Phase 1 completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (Phase 3 clinical trial, status unknown).