Celltrion announced that the European Commission (EC) has approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar referencing Stelara®, for the treatment of multiple chronic inflammatory diseases. SteQeyma is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications. Stelara was the first biologic therapy for Crohn?s disease to target interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses.

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). SteQeyma®, formerly known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. SteQeyma is available in both subcutaneous and intravenous formulations.

The subcutaneous injection comes 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.