[Edaily Reporter KIM SAE-MI ] Celltrion(068270)has applied for European marketing authorization for “CT-P55,” a biosimilar of the autoimmune disease treatment Cosentyx.

Celltrion announced on the 24th that it had submitted a marketing authorization application for CT-P55 to the European Medicines Agency (EMA).

The active ingredient in CT-P55 is secukinumab. Celltrion has applied for approval for all indications currently held by Cosentyx in Europe, including adult plaque psoriasis, pustular psoriasis, psoriatic arthritis, and axial spondyloarthritis, as well as pediatric plaque psoriasis and juvenile idiopathic arthritis.

This application was based on the results of a Phase 1 clinical trial involving 172 healthy adult males aged 18 to 55. The trial compared the pharmacokinetics, safety, and immunogenicity of CT-P55 with those of Cosentyx.

The 90% confidence intervals for the primary endpoints—the area under the plasma concentration-time curve (AUC0-inf) and maximum plasma concentration (Cmax)—fell within the pre-specified equivalence range. Safety and immunogenicity were also similar between the two treatment groups.

Adverse events following administration were reported in 65.5% of all subjects, and most were mild or moderate in severity. One serious adverse event occurred in the Cosentyx group.

Following its application for the first marketing authorization for CT-P55 in Canada last May, Celltrion submitted an application for approval in South Korea in June. With this European application, the company plans to sequentially pursue country-specific approvals and commercialization preparations.

CT-P55 is a biosimilar of Cosentyx, an interleukin (IL)-17A inhibitor. Cosentyx recorded global sales of approximately $6.668 billion (about 10 trillion won) last year. Celltrion expects that, if the approval process proceeds smoothly, CT-P55 could be launched as part of the “first group” of secukinumab biosimilars.

With the addition of CT-P55, Celltrion’s portfolio of treatments for autoimmune diseases will expand to include IL-17A inhibitors, following its existing portfolio of tumor necrosis factor (TNF)-α, IL-6, and IL-12/23 inhibitors.

A Celltrion spokesperson stated, “Following Canada and South Korea, we have completed the marketing authorization application in Europe as well,” adding, “We will lay the groundwork for commercialization with the goal of a ‘first-group’ launch.”