Celltrion Gains FDA Approval for New STEQEYMA® Dose for Paediatric Patients
Monday, June 16, 2025
Celltrion has announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab).
STEQEYMA, previously known as CT-P43, is a human interleukin (IL)-12 and IL-23 antagonist. It is indicated for the treatment of several immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It is available in subcutaneous and intravenous forms. The subcutaneous formulations include 45mg/0.5mL and 90mg/1mL in prefilled syringes, as well as a 45mg/0.5mL vial. The intravenous version is offered as a 130mg/26mL solution in a single-dose vial.
The approval covers a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. This new format is indicated for children aged 6 to 17 years, weighing under 60kg, who are being treated for plaque psoriasis (PsO) or psoriatic arthritis (PsA).
This latest approval means that STEQEYMA now mirrors all dosage forms and strengths of its reference medicine, providing healthcare professionals with increased flexibility in managing treatment for both adult and paediatric patients.
Previously, in December 2024, the FDA approved STEQEYMA in multiple formats, including 45mg/0.5mL and 90mg/mL solutions in prefilled syringes for subcutaneous use, and 130mg/26mL for intravenous infusion. These were approved for use in adults and children aged 6 years and above with PsO and PsA, and for adults with Crohn’s disease and ulcerative colitis.
The newly approved presentation is designed to support more tailored treatment approaches in children and aligns with the full range of indications of the original reference product.
The FDA’s approval was based on comprehensive data, including findings from a phase III clinical study involving adults with moderate to severe plaque psoriasis.
The results confirmed that STEQEYMA closely matches the reference product in terms of safety, efficacy, and overall clinical performance.
Source: celltrion.com
