EC approves Celltrion's SteQeyma for chronic inflammatory diseases

The European Commission (EC) has granted approval to Celltrion’s SteQeyma (CT-P43), a biosimilar version of Stelara (ustekinumab), for the treatment of several chronic inflammatory diseases. This decision includes indications across the fields of gastroenterology, dermatology, and rheumatology, following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June.

SteQeyma, formerly known as CT-P43, functions as an antagonist to human IL-12 and IL-23, thereby addressing various immune-mediated conditions. It is offered in both subcutaneous and intravenous formulations. The subcutaneous option is available in 45mg/0.5ml or 90mg/1ml doses contained in a prefilled syringe, while the intravenous infusion is provided as a 130mg/26ml (5mg/ml) solution in a single-dose vial.

Stelara, the reference product for SteQeyma, is a biologic therapy that targets interleukin (IL)-12 and IL-23 cytokines, which are essential for inflammatory and immune responses.

The EC’s approval of SteQeyma is based on comprehensive clinical evidence, including a pivotal Phase III trial in adults with moderate to severe plaque psoriasis. The study's primary endpoint focused on the change rate in the Psoriasis Area and Severity Index (PASI) for skin symptoms. Clinical data verified that SteQeyma is highly similar to Stelara, showing no significant differences in efficacy and safety.

SteQeyma is now the seventh biosimilar from Celltrion to secure EU approval. It joins a portfolio that already includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo. Earlier in May, the EC approved Omlyclo, an omalizumab biosimilar referencing Xolair, for treating allergic conditions.

Taehun Ha, senior vice-president and head of Celltrion’s Europe Division, commented: “The EC approval of SteQeyma provides a significant new therapeutic option for patients. We are enthusiastic about launching this innovative therapy, which has a proven track record in treating Crohn’s disease and other immune-related conditions. This approval, along with those of Remsima SC and Yuflyma, is a crucial milestone in our strategy to enhance Celltrion’s immunology offerings. With the recent approval of Omlyclo in May, we are excited about expanding our portfolio into the dermatology sector. This development underscores our dedication to increasing patient access to affordable, high-quality biologic medicines.”