Biosimilar ustekinumab demonstrates therapeutic equivalance to Stelara for treatment of psoriasis
Meiji Seika Pharma announced that its biosimilar version of Stelara (ustekinumab) being developed with South Korean partner Dong-A ST demonstrated its therapeutic equivalence to the reference product in a global Phase III study for the treatment of psoriasis. Based on these results, the companies plan to file the drug in the US, Europe, and Japan within 2023
The study enrolled 605 plaque psoriasis patients in eight European countries (Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Poland, Ukraine) and the US, with Japan not included. The biosimilar, DMB 3115, and Stelara demonstrated their therapeutic equivalence in the primary endpoint of the study, or a percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12. There was no clinically significant difference in safety.
Meiji Pharma has been granted the rights to develop and commercialize DMB-3115 in Japan. Aside from the PIII study, the Japanese company is also running a domestic PI study for the biosimilar.
Patents for Stelara expire in July 2025 in the EU and in September 2023 in the US.
Related news and insights
Ionis Pharmaceuticals announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase III studies evaluating the safety and efficacy of GSK 3228836 (bepirovirsen) (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB)
Idorsia announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for ACT 132577 (aprocitentan), Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension