FDA Approves Steqeyma for Children With Plaque Psoriasis, Psoriatic Arthritis

Celltrion announced the FDA had approved a new formulation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). The approval, for a 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection, significantly broadened dosing flexibility for pediatric patients aged 6 to 17 years who weigh less than 60 kg and live with plaque psoriasis (PsO) or psoriatic arthritis (PsA).

The company stated that the strategic expansion ensures that Steqeyma now aligns with all existing dosage forms and strengths of its reference product, providing enhanced options for health care providers and individuals managing these chronic inflammatory conditions.

The FDA's decision marked a pivotal moment for pediatric dermatology and rheumatology, offering a precise dosing solution for a vulnerable patient population. Prior to this latest approval, in December 2024, the FDA had already granted approval for Steqeyma in 45 mg/0.5 mL and 90 mg/mL solutions in single-dose prefilled syringes for subcutaneous injection and a 130 mg/26 mL solution in a single-dose vial for intravenous infusion.2

These initial approvals covered adult and pediatric patients aged 6 years and older with PsO and PsA, as well as adult patients with Crohn disease and ulcerative colitis. The addition of the new 45 mg/0.5 mL single-dose vial specifically addresses the nuanced requirements for precise weight-based dosing in smaller pediatric patients.

"Managing inflammatory diseases in pediatric patients can be particularly complex due to varying body weights and specific developmental needs," stated Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA.1 "This new dosage form and strength of Steqeyma allows 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." This sentiment underscored the commitment to patient-centered care, a priority for managed care organizations focused on optimizing health outcomes and treatment adherence.

Thomas Nusbickel, chief commercial officer at Celltrion USA, emphasized the broader impact of the approval. "We are proud to offer a new presentation of Steqeyma that aligns with the indications of the reference product. This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions."

The FDA’s approval of Steqeyma was built upon a comprehensive body of evidence, including the results from a phase 3 study conducted in adults with moderate to severe PsO. This study demonstrated that Steqeyma and the reference product exhibited high similarity, confirming no clinically meaningful differences in terms of safety and efficacy among adult individuals.3

A key development for formulary decision-makers was the FDA’s decision to grant Steqeyma full interchangeability with Stelara across all its indications.1 Interchangeability status allows for direct pharmacy-level substitution, further simplifying access and potentially reducing health care costs.

The expanded approval of Steqeyma for pediatric patients represents a significant advancement in the treatment landscape for individuals living with PsO and PsA. By providing a full complement of dosage forms and strengths, Celltrion aims to enhance treatment continuity and improve access to a crucial therapeutic option, aligning with the core objectives of managed care to deliver high-quality, cost-effective care.

References

1. Celltrion announces U.S. FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients. Press release. Celltrion; June 15, 2025. Accessed June 17, 2025. https://www.prnewswire.com/news-releases/celltrion-announces-us-fda-approval-of-additional-presentation-of-steqeyma-ustekinumab-stba-expanding-dosing-options-for-pediatric-patients-302481004.html

2. Jeremias S. FDA approves Steqeyma: the seventh Stelara biosimilar. The Center for Biosimilars®. December 18, 2024. Accessed June 17, 2024. https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar

3. Papp KA, Lebwohl MG, Thaçi D, et al. Efficacy and safety of candidate biosimilar CT-P43 versus originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomized, active-controlled, double-blind, phase III study. BioDrugs. 2024;38:121-131. doi: 10.1007/s40259-023-00630-5