European Commission Approves Celltrion’s Stelara Biosimilar SteQeyma

Celltrion announced that the European Commission (EC) has approved SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases, including psoriasis.

The EC's approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024. The decision was based on evidence, including data from a phase 3 clinical trial involving adults with moderate to severe plaque psoriasis. The study demonstrated that SteQeyma is highly similar to its reference product, Stelara, with no clinically meaningful differences in terms of efficacy and safety. The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI), a key measure of treatment effectiveness for skin symptoms.

SteQeyma, also known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for the treatment of multiple immune-mediated diseases. It is available in both subcutaneous and intravenous formulations. The subcutaneous injection is offered in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.

SteQeyma is Celltrion’s seventh biosimilar to receive approval in the European Union (EU).