Celltrion is set to begin a Phase 1 clinical trial for its biosimilar of the autoimmune disease treatment Tremfya (active ingredient: guselkumab). This move is part of the company's strategy to expand its biosimilar development and strengthen its portfolio in autoimmune disease treatments.
On July 15, Celltrion announced that it has received approval from the Ministry of Food and Drug Safety for the investigational new drug (IND) application for its Tremfya biosimilar, designated CT-P68.
Tremfya is a treatment that selectively inhibits the interleukin (IL)-23 protein involved in inflammation, and it is used for conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
In this clinical trial, Celltrion plans to evaluate the safety and pharmacokinetic equivalence of CT-P68 compared to Tremfya in 258 healthy adults. Last year, global sales of Tremfya were reported to be approximately $5.155 billion (about 7.7 trillion won).
Celltrion is also accelerating the expansion of its autoimmune disease treatment portfolio. The biosimilar of Entyvio (active ingredient: vedolizumab), CT-P45, has received approval for Phase 1 clinical trials in both the U.S. and South Korea. This treatment is an integrin inhibitor that selectively suppresses specific immune cells that migrate to the intestinal mucosa.
Additionally, this year, Celltrion launched the autoimmune disease treatment Aptozma (active ingredient: tocilizumab) in Japan and has applied for product approval for the biosimilar of Cosentyx (secukinumab), CT-P55, in Canada, further expanding its global market reach. The company is also developing biosimilars for the cancer treatments Keytruda and Darzalex.
A Celltrion representative stated, "We will accelerate the development of subsequent biosimilars to secure growth momentum and strengthen our dominance in the global autoimmune disease treatment market."
Meanwhile, Celltrion announced on July 3 that it recorded consolidated sales of 1.3 trillion won and an operating profit of 430 billion won for the second quarter of 2026.
* This article has been translated by AI.
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