India, June 15 -- Celltrion Inc. announced that the U.S. Food and Drug Administration approved a new presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).
With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, STELARA.
In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous inf...