[Press Release] On June 15, Celltrion 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).[1] 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 pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.

"Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile."

"We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages."

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 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.[2],[3]

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.