Celltrion announced on the 24th that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for CT-P55, a biosimilar referencing the blockbuster autoimmune therapy Cosentyx (active ingredient: secukinumab).
The application seeks approval for the full scope of European indications held by the reference drug, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
In clinical trials conducted ahead of the filing, CT-P55 demonstrated equivalent pharmacokinetics—specifically absorption and distribution in the body—compared to Cosentyx. The biosimilar candidate also exhibited comparable safety and immunogenicity profiles.
The European submission marks the third regulatory filing for CT-P55, following applications in Canada in May and South Korea in June. Celltrion plans to accelerate approval procedures in key global markets while sequentially advancing country-by-country regulatory reviews and commercialization preparations.
Expanding Portfolio into the Interleukin-17A Category
CT-P55 is a biosimilar to Cosentyx, an interleukin (IL)-17A inhibitor. The reference product is an industry blockbuster that posted global sales of approximately $6.668 billion (around 10 trillion KRW) last year.
Celltrion has steadily built its global market presence by supplying a broad spectrum of autoimmune treatments, including Remsima, Remsima SC (marketed in the U.S. as Zymfentra), Yuflyma, Steqeyma, and Avtozma. Adding CT-P55 will expand Celltrion’s autoimmune portfolio beyond TNF-α, IL-6, and IL-12/23 inhibitors to encompass the IL-17A inhibitor class.
"Following Canada and South Korea, we have completed the marketing authorization application for CT-P55 in Europe as well, moving in earnest to advance the approval process for entry into major global markets," a Celltrion official said.
