Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options
Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formulation is now indicated for pediatric patients aged 6 to 17 years weighing under 60kg with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, STEQEYMA now mirrors all dosage forms and strengths of its reference product, STELARA, expanding treatment flexibility and continuity for younger patient populations.
“The new dosage form and ...