On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection. The formulation is intended for pediatric patients (ages 6–17) under 60kg with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA, including 45mg/0.5mL and 90mg/mL prefilled syringes (subcutaneous), and 130mg/26mL vials (intravenous). According to Celltrion, the new dosage form is intended to give physicians more flexibility while maintaining STEQEYMA’s safety and efficacy. Following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025, STEQEYMA has also been granted full interchangeability with STELARA across all indications.
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