On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications. Celltrion is also planning regulatory filings for CT-P55 in the US, Europe and Korea.
According to Celltrion, its first biosimilar secukinumab application was filed in Canada on the basis that it is a “pro-biosimilar nation” and pursues “policies to promote the introduction of biosimilars and [improve] its regulatory environment”.
The Canadian application is based on Celltrion’s Phase 1 trials, results of which were presented in September 2025. In February 2026, Celltrion received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial 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 currently recruiting).