Long-term clinical results for Celltrion's (068270) autoimmune disease treatment Stekima have been published in an international dermatology journal. The confirmation of therapeutic efficacy and safety comparable to the original drug is expected to boost the company's global market expansion.
Celltrion announced on the 6th that the 52-week results from Stekima's global Phase 3 clinical trial have been published in the international dermatology journal Dermatologic Therapy.
The study represents long-term follow-up results from a global Phase 3 clinical trial involving 509 patients with moderate to severe plaque psoriasis. Researchers conducted a comprehensive analysis comparing Stekima with the original drug across efficacy, safety, immune response, and pharmacokinetics.
The trial initially divided patients into a Stekima treatment group and an original drug treatment group. From week 16, some patients were switched from the original drug to Stekima, with therapeutic effects tracked through week 52.
Results showed similar therapeutic efficacy between the Stekima and original drug treatment groups. Patients who switched from the original drug to Stekima also maintained stable therapeutic effects. No significant differences in adverse event rates were observed between the two treatment groups.
Celltrion previously presented the same clinical data at the European Academy of Dermatology and Venereology (EADV) conference in 2023. The company expects the journal publication to further enhance prescribing confidence among medical professionals.
Stekima is a biosimilar of the global blockbuster drug Stelara. It has received approval in major markets including the United States, Europe, and Australia, with launches proceeding sequentially. According to market research firm IQVIA, the global market for ustekinumab-based drugs is estimated at approximately $21.6 billion (about 30 trillion won).
Celltrion is expanding its influence in the autoimmune disease treatment market by adding interleukin (IL)-class therapeutics to its portfolio, which already includes tumor necrosis factor-alpha (TNF-α) inhibitors such as Remsima, Remsima SC, and Yuflyma.
A Celltrion official stated, "The publication of Stekima's global clinical results in an international journal reaffirms its competitiveness as a long-term treatment option," adding, "We plan to further accelerate product growth in major global markets."