The European Commission (EC) has approved the use of Celltrion’s SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases.
SteQeyma, which targets interleukin (IL)-12 and IL-23 cytokines, is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications.
The decision from the EC follows a positive opinion recommending SteQeyma from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.
The EC approval of SteQeyma was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that SteQeyma is highly similar to its reference product, Stelara, and has no clinically meaningful differences in terms of efficacy and safety.
SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU). Alongside Remsima SC, a subcutaneous formulation of infliximab approved in the EU, SteQeyma joins Celltrion’s distinguished portfolio that includes Remsima (biosimilar infliximab), Truxima (biosimilar rituximab), Herzuma (biosimilar trastuzumab), Yuflyma (biosimilar adalimumab), Vegzelma (biosimilar bevacizumab) and Omlyclo (biosimilar omalizumab).
