South Korea-based Celltrion has announced that the European Commission (EC) has approved SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating several chronic inflammatory diseases.
SteQeyma, previously known as CT-P43, is now authorised as a biologic therapy for indications in gastroenterology, dermatology, and rheumatology.
Stelara, the reference biologic, was the first therapy for Crohn’s disease to target interleukin (IL)-12 and IL-23 cytokines.
The European Commission’s decision to approve SteQeyma followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.
The approval was based on a comprehensive review of evidence, including data from a Phase 3 study involving adults with moderate to severe plaque psoriasis.
The study’s primary endpoint was the change in the Psoriasis Area and Severity Index (PASI) for skin symptoms.
According to the results, SteQeyma was found highly similar to its reference product, Stelara, with no significant differences in efficacy or safety.
Celltrion Europe division head and senior vice president Taehun Ha said: “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases.
“This approval, alongside those of Remsima SC and Yuflyma, marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector.
“We believe the approval demonstrates our unwavering commitment to expanding patient access to affordable, high-quality biologic medicines.”
SteQeyma is offered in both subcutaneous and intravenous formulations. The subcutaneous option is available in 45mg/0.5mL and 90mg/1mL, both provided in single-dose prefilled syringes.
The intravenous formulation is available as a 130mg/26mL solution in a single-dose vial.
SteQeyma is the seventh biosimilar from Celltrion to receive approval in the European Union. It joins a portfolio that already includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo.
Recently, Celltrion divested the asset rights of 14 branded products to Hasten Biopharmaceutical.
