Celltrion announced in a regulatory filing on the 30th that it has completed submitting a marketing authorization application to the U.S. Food and Drug Administration (FDA) for its Cosentyx (Secukinumab) biosimilar 'CT-P55.' The application date is July 30, 2026, local time.

This authorization application covers six indications: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa.

The company presented clinical data secured as the basis for the application. The Phase 1 clinical trial compared and evaluated the pharmacokinetics, safety, and immunogenicity of CT-P55 and the original drug Cosentyx in 172 healthy adult males aged 18 to 55.

The clinical results demonstrated pharmacokinetic equivalence between the two drugs, as the 90% confidence intervals for the primary endpoints, AUC0-inf and Cmax, fell within the pre-defined equivalence criteria. In the safety evaluation, treatment-emergent adverse events (TEAEs) were reported in 65.5% of all subjects, with similar incidence rates between CT-P55 and Cosentyx. Most cases were mild or moderate, and one serious adverse event occurred in the Cosentyx treatment group. In the immunogenicity evaluation, the incidence of ADA/NAb development against Secukinumab was generally low and similar across the three groups, with no clinically significant safety impact observed.

Celltrion plans to sequentially apply for marketing authorization in other countries going forward, starting with this U.S. application. The company expects that this will provide more treatment options for patients with the relevant indications.

However, the company noted as an investor caution that applying for authorization for the clinical trial drug does not guarantee final approval from regulatory authorities, and that commercialization plans may be altered or discontinued depending on the review results.