Celltrion, Inc. 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).
With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in thePsoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.
