Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for paediatric patients with plaque psoriasis or psoriatic arthritis under 60 kg.
Celltrion today announced that the US FDA has approved a new presentation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), in a 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection.
