Celltrion files for EU approval of Cosentyx biosimilar CT-P55, targeting W10tr market

Celltrion said Friday it has filed for marketing authorization with the European Medicines Agency for CT-P55, a biosimilar of the autoimmune drug Cosentyx (secukinumab).

The application covers all indications held by the original drug in Europe, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.

Celltrion said clinical trials demonstrated pharmacokinetic equivalence with the original drug, along with comparable safety and immunogenicity profiles. The EMA filing follows earlier submissions in Canada in May and South Korea in June, as the company moves to advance regulatory processes across major global markets and prepare for commercialization on a rolling basis.

Cosentyx, the reference product for CT-P55, is an interleukin (IL)-17A inhibitor that recorded global sales of approximately $6.67 billion last year, making it a blockbuster product. IL-17A is a protein that plays a central role in triggering inflammatory responses, and CT-P55 — which targets and blocks it — is a strategic pipeline addition Celltrion is counting on to strengthen its foothold in the autoimmune disease market. If the regulatory process proceeds without setbacks, Celltrion expects CT-P55 to enter the secukinumab biosimilar market as part of the "first group" of early launchers, giving it a head start in capturing market share.

With CT-P55 added to its lineup, Celltrion's autoimmune portfolio would expand from existing inhibitors targeting TNF-α (tumor necrosis factor), IL-6 and IL-12/23 to now include the IL-17A class as well. The company has already built a presence in the space through products including Remsima, Zymfentra (the US brand name for Remsima SC), Yuflyma, Steqeyma and Eptozma.

"We have completed the European marketing authorization application and are now moving in earnest to enter major global markets," a Celltrion official said. "We will quickly lay the commercial groundwork with the goal of a first-group launch and solidify our position in the autoimmune disease treatment market."

Meanwhile, Celltrion is pushing ahead with development of additional pipeline candidates — including biosimilars of Ocrevus (CT-P53), Taltz (CT-P52) and Keytruda (CT-P51) — as part of its plan to expand its current lineup of 11 biosimilar products to 18 by 2030.