The 52-week long-term Phase 3 global clinical trial data for Celltrion’s autoimmune disease treatment “Steqeyma (ingredient name: ustekinumab)” has been published in the international dermatology journal “Dermatologic Therapy.” Building on this, Celltrion plans to strengthen medical professionals’ confidence in the product and accelerate efforts to expand its global market share.

This study is a long-term clinical trial involving 509 patients with moderate to severe plaque psoriasis, comprehensively comparing and evaluating Steqeyma’s efficacy, safety, immunogenicity, and pharmacokinetics with those of the reference biologic. The trial was conducted with an initial Steqeyma treatment arm and a reference product treatment arm; from week 16, part of the reference product arm was switched to Steqeyma and followed up to week 52.

According to the results, efficacy was similar between the Steqeyma arm and the reference product arm, and efficacy was stably maintained in the switch group that transitioned from the reference product to Steqeyma. In terms of safety, no clinically meaningful differences in adverse events were observed across all treatment arms, which was assessed as demonstrating the clinical validity of switching and long-term administration.

Celltrion first presented these clinical results in poster form at the 2023 European Academy of Dermatology and Venereology (EADV) congress. With the data now also accepted by an international academic journal following a leading conference, the company expects prescribing preference and trust among clinicians to increase further.

Steqeyma is a biosimilar of the autoimmune disease blockbuster “Stelara” and has obtained approvals in major markets including the United States, Europe, and Australia, where it is being launched sequentially. According to the pharmaceutical market research firm IQVIA, the global ustekinumab market reached approximately USD 21.6 billion (about KRW 30 trillion) in 2024.

Following its existing TNF-α inhibitor portfolio, Celltrion is expanding into the interleukin (IL) inhibitor class to which Steqeyma belongs, thereby increasing its influence in the autoimmune disease market.

A Celltrion official said, “Through this journal publication, the competitiveness of Steqeyma as a long-term treatment option has been reconfirmed,” adding, “We plan to further expand the strong growth trajectory of Steqeyma, which is rapidly gaining traction in major global markets.”

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