The European Commission (EC) has granted marketing authorization for Celltrion's SteQeyma (CT-P43), a biosimilar referencing Stelara (ustekinumab), for the treatment of several chronic inflammatory diseases. This approval spans indications in gastroenterology, dermatology, and rheumatology, marking a significant step in providing a more accessible treatment option for patients with these conditions. The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.
SteQeyma acts as an antagonist to human IL-12 and IL-23, cytokines known to play a key role in inflammatory and immune responses. Stelara, the reference product, was the first biologic therapy for Crohn’s disease to target these interleukins.
The EC's approval was primarily based on a Phase III clinical trial involving adults with moderate to severe plaque psoriasis. The study's primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) score, a measure of skin symptom severity. Results indicated that SteQeyma is highly similar to Stelara, with no clinically meaningful differences observed in terms of efficacy and safety profiles.
Clinical Trial Data
The Phase III trial evaluated the efficacy and safety of SteQeyma in comparison to Stelara in patients with moderate to severe plaque psoriasis. The clinical data confirmed that SteQeyma's efficacy and safety are comparable to Stelara. The primary endpoint, the change in PASI score, demonstrated a similar reduction in skin symptoms between the two treatment groups.
SteQeyma is available in both subcutaneous and intravenous formulations. The subcutaneous injection is offered in strengths of 45mg/0.5ml and 90mg/1ml in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial.
Celltrion's Expanding Portfolio
SteQeyma is the seventh biosimilar from Celltrion to receive EU approval, joining a portfolio that includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma and Omlyclo. Celltrion aims to strengthen its immunology offering and expand its portfolio into the dermatology sector.
"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," said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion. "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."
