The European Commission (EC) has approved Celltrion's SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions.
This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year.
SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases.
It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial.
Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses.
The EC's decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque psoriasis.
The study's primary endpoint was the change rate in the Psoriasis Area and Severity Index (PASI) for skin symptoms.
Clinical data confirmed that SteQeyma is highly similar to Stelara, without any significant differences in efficacy and safety.
SteQeyma is claimed to be the seventh biosimilar of Celltrion to receive EU approval, joining a portfolio that includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo.
In May this year, the EC approved Omlyclo, a omalizumab biosimilar for reference product Xolair, to treat allergic conditions.
Celltrion Europe Division senior vice-president and head Taehun Ha said: “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.
“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.”
