Celltrion received approval for a domestic phase 3 clinical trial of’CT-P43′, a biosimilar of’Stellara’ (ingredient name: Ustekinumab), an autoimmune disease treatment.
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According to the Celltrion disclosure, the Ministry of Food and Drug Safety approved Phase 3 of CT-P43 for patients with moderate or severe plaque (plaque) psoriasis on the 7th.
Celltrion plans to compare the effectiveness and safety of CT-P43 and Stellara through Phase III in Korea. Stellara, an interleukin (IL) inhibitor, is an autoimmune disease treatment developed by global pharmaceutical company Janssen.
Earlier, Celltrion entered the global phase 3 of CT-P43 for the same indication in December of last year, and this domestic clinical trial is part of a global clinical trial. Of the 3 phases of 446 subjects, 50 subjects were conducted at 7 clinical trial institutes in Korea.
Celltrion has announced that it will commercialize the CT-P43 in September 2023, when Stellara’s US material patent expires, and in July 2024, when the European material patent expires.
Celltrion said, “The availability of target biological agents such as Ustekinumab, Infliximab, Adalimumab, and Etanercept, which are currently developed for the treatment of psoriasis, revolutionize the treatment of psoriasis. “This has improved the patient’s treatment outcome, but it has incurred much higher financial costs than existing treatment options, and the development of a biosimilar can reduce the financial burden of these patients.”
He said, “We can expect to expand the market and increase sales through approval of approval for all indications for which the original product has been approved, as well as plaque psoriasis.”
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