South Korea-based biopharmaceutical company Celltrion Inc announced on Sunday that the US 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 paediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). The company says that 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.

In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and paediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.

The FDA's STEQEYMA approval 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 the Psoriasis 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 30 April 2025.