Celltrion has taken another step toward expanding its presence in the global autoimmune disease treatment market by filing for European approval of its Cosentyx biosimilar, CT-P55. Following regulatory submissions in Canada and South Korea, the company is now seeking approval in Europe as it accelerates efforts to capture a share of the global secukinumab market.
Celltrion announced Friday that it has submitted a marketing authorization application for CT-P55, a biosimilar of Cosentyx (secukinumab), to the European Medicines Agency (EMA).
The application covers all indications currently approved for the reference product in Europe, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.
According to the company, clinical studies demonstrated biosimilarity and therapeutic equivalence between CT-P55 and the reference drug. The biosimilar met pharmacokinetic (PK) equivalence endpoints and showed comparable safety and immunogenicity profiles.
The filing follows Celltrion’s regulatory submission to Health Canada in May and its application to South Korea’s Ministry of Food and Drug Safety in June. With the European filing, the company is now pursuing approvals across several key global markets simultaneously as it prepares for commercialization.
CT-P55 targets a significant market opportunity. The reference drug, Cosentyx, generated approximately $6.67 billion in global sales last year, making it one of the world’s leading blockbuster treatments for autoimmune diseases.
Secukinumab is an interleukin-17A (IL-17A) inhibitor that selectively blocks a key inflammatory pathway. It is widely used to treat autoimmune diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis due to its strong efficacy and favorable safety profile.
Celltrion expects CT-P55 to be among the first wave of secukinumab biosimilars to reach the market if regulatory approvals proceed as planned. In the biosimilar industry, early market entry is considered a key advantage for gaining market share and expanding physician adoption.
The addition of CT-P55 would further strengthen Celltrion’s autoimmune disease portfolio.
The company currently markets several biosimilars globally, including Remsima, Remsima SC (marketed as Zymfentra in the United States), Yuflyma, SteQeyma and Avtozma.
Once commercialized, CT-P55 would expand Celltrion’s autoimmune portfolio beyond its existing tumor necrosis factor-alpha (TNF-α) inhibitors into the IL-17A inhibitor segment. Combined with its IL-6 and IL-12/23 therapies, the company would offer a broader range of treatment options across autoimmune diseases.
Celltrion is also advancing additional biosimilar candidates. In autoimmune diseases, it is developing CT-P53, a biosimilar of Ocrevus, and CT-P52, a biosimilar of Taltz. In oncology, the company is expanding its pipeline with CT-P51, a biosimilar of Keytruda, and CT-P44, a biosimilar of Darzalex.
The company aims to expand its commercial biosimilar portfolio from the current 11 products to 18 by 2030 as it strengthens its position in the global biosimilar market.
“Following our regulatory filings in Canada and South Korea, we have now completed our European submission for CT-P55, marking another important step toward entering major global markets,” a Celltrion spokesperson said. “We will work to complete the approval process smoothly with the goal of launching as part of the first wave of secukinumab biosimilars and further strengthening our competitiveness in the global autoimmune disease treatment market.”
Separately, Celltrion ranked first in the pharmaceutical and biotechnology category of this month’s K-Brand Index, a big data-based brand ranking.
The survey analyzed more than 18.04 million pieces of online big data collected between June 1 and June 30 from leading pharmaceutical and biotechnology companies.