EC Approves Celltrion's SteQeyma® Biosimilar for Chronic Inflammatory Diseases
Monday, August 26, 2024
Celltrion has announced that the European Commission (EC) has granted approval for SteQeyma® (CT-P43), a biosimilar of ustekinumab referencing Stelara®, for the treatment of several chronic inflammatory conditions.
SteQeyma®, previously known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases.
It is available in both subcutaneous and intravenous forms. The subcutaneous injection is offered in two strengths: 45mg/0.5 mL or 90mg/1 mL in a single-dose prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.
This EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.
The EC's decision was based on comprehensive evidence, including data from a Phase III clinical trial involving adults with moderate to severe plaque psoriasis. The primary measure was the change in the Psoriasis Area and Severity Index (PASI) for skin symptoms
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SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU).
SteQeyma is authorised for use as a biologic therapy in the fields of gastroenterology, dermatology, and rheumatology. Stelara was the pioneering biologic therapy for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines, which are crucial in inflammatory and immune responses.
The results showed that SteQeyma is highly comparable to its reference product, Stelara, with no significant differences in efficacy and safety.
The EC approval of SteQeyma introduces a significant new treatment option for patients, and we are eager to launch this therapy, which has demonstrated success in treating Crohn’s and other immune-related diseases.
This approval, along with those for Remsima SC and Yuflyma, is a key step in our strategy to enhance Celltrion’s immunology offerings. With the recent approval of Omlyclo in May, we are also looking forward to expanding our portfolio in the dermatology sector.
This approval reflects our dedication to increasing patient access to high-quality, affordable biologic medicines.
It joins a distinguished portfolio that includes Remsima® SC (a subcutaneous formulation of infliximab), Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), Vegzelma® (biosimilar bevacizumab), and Omlyclo® (biosimilar omalizumab).
Source:celltrion.com
