Celltrion announced on the 24th that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Cosentyx (Secukinumab) biosimilar candidate 'CT-P55.' The application date is July 24, 2026, based on local time.

The indications included in this application are adult plaque psoriasis, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), pediatric plaque psoriasis, and pediatric idiopathic arthritis (enthesitis-related arthritis and pediatric psoriatic arthritis).

Celltrion also disclosed the clinical data secured as the basis for the application. According to the company, the Phase 1 clinical trial was conducted on 172 healthy adult males to compare the pharmacokinetics (PK), safety, and immunogenicity of CT-P55 with those of the reference medicinal product (original), Cosentyx. The trial design was double-blind, randomized, and active-controlled.

Based on the clinical results, the company explained that the 90% confidence intervals for the primary evaluation parameters, AUC0-inf and Cmax, fell within the pre-defined equivalence criteria, thereby demonstrating pharmacokinetic equivalence between CT-P55 and Cosentyx.

In the safety evaluation, treatment-emergent adverse events were reported in 65.5% of all subjects, with similar incidence rates between the CT-P55 and Cosentyx groups. Most of the reported adverse events were mild or moderate in severity, and one case of treatment-emergent serious adverse events occurred in the Cosentyx treatment group.

In the immunogenicity evaluation, the incidence of ADA and NAb against Secukinumab was generally low and similar between groups, with no clinically meaningful safety impact related to immunogenicity observed.

Celltrion stated that it has completed the European application based on the secured clinical data and plans to continue submitting applications country by country. The company expects that if this application is approved, it will be able to provide treatment opportunities to a larger number of patients.

However, the company disclosed that while the application was filed based on clinical trial results, it does not guarantee final approval from drug regulatory authorities, and the commercialization plan may be altered or discontinued depending on the review outcome.