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Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has 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).[1] With this approval, STEQEYMA now offers all dosage fo

articleCelltrion, Inc.June 15, 20258/company/celltrion-inc/news/celltrion-announces-u-fda-approval-233000068
Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

About this update from Celltrion, Inc.

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More updates from Celltrion, Inc.

Celltrionpsoriatic arthritissubcutaneous injectionFDAplaque psoriasisCrohn's diseasepediatric patientsulcerative colitisSTEQEYMAintravenous infusionSTELARAprefilled syringe