On June 15, 2025, the FDA announced the approval of a new presentation of ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinumab (Stelara; Janssen Biotech), in a 45mg / 0.5mL solution in a single-dose vial for subcutaneous injection. The biosimilar is indicated for patients aged 6 to 17 years (< 60 kg) with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With the approval, ustekinumab-stba offers all dosing forms of the reference product, according to a press release from Celltrion.¹

Previously, the FDA approved ustekinumab-stba 45mg/0.5mL, 90mg / mL in a single-dose prefilled syringe for subcutaneous injection, and 130mg / 26mL in a single-dose vial for intravenous infusion in December 2024.

"Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD, MBA, vice president, Medical Affairs, Celltrion USA, in a statement. "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."

Approval for the biosimilar was based on the results from a phase 3 study in adults with moderate-to-severe PsO, where the primary endpoint was the rate of change in the Psoriasis Area and Severity Index for skin symptoms. Results demonstrated high similarity between ustekinumab-stba and ustekinumab, and have "no clinically meaningful differences in terms of safety and efficacy."

Other biosimilars to ustekinumab

Following the FDA approval of ustekinumab on August 1, 2022, multiple biosimilars have been approved by the FDA. Click on the link below to read more about each biosimilar.

• On October 31, 2023, the FDA approved ustekinumab-auub (Wezlana; Amgen) as an interchangeable biosimilar to ustekinumab to treat patients aged 6 years and older with moderate-to-severe plaque psoriasis (candidates for phototherapy or systemic therapy) and for those with active psoriatic arthritis. Click here for more.³
• On April 23, 2024, the FDA approved ustekinumab-aekn (SELARSDI; Alvotech and Teva Pharmaceuticals) to treat moderate-to-severe plaque psoriasis, as well as active psoriatic arthritis, in adults and pediatric patients aged 6 years and up. Click here for more.⁴
• On July 9, 2024, the FDA approved ustekinumab-ttwe (Pyzchiva; Samsung Bioepis) for all indications of its reference ustekinumab. Click here for more.⁵

References:

1. Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA (ustekinumab-stba), expanding dosing options for pediatric patients. Celltrion Inc. Press release. June 15, 2025. Accessed June 16, 2025. https://www.celltrionusa.com/board/newslist/40

2. Bader K. FDA approves ustekinumab to treat pediatric psoriatic arthritis. August 1, 2022. Accessed June 16, 2025. https://www.contemporarypediatrics.com/view/fda-approves-ustekinumab-to-treat-pediatric-psoriatic-arthritis

3. Fitch J. Ustekinumab biosimilar approved for children 6 years and up with plaque psoriasis, psoriatic arthritis. November 7, 2023. Accessed June 16, 2025. https://www.contemporarypediatrics.com/view/ustekinumab-biosimilar-approved-for-children-6-years-and-up-with-plaque-psoriasis-psoriatic-arthritis

4. Fitch J. Ustekinumab biosimilar approved to treat moderate to severe plaque psoriasis. Contemporary Pediatrics. April 23, 2024. Accessed June 16, 2025. https://www.contemporarypediatrics.com/view/ustekinumab-biosimilar-approved-to-treat-moderate-to-severe-plaque-psoriasi

5. Fitch J. FDA approves ustekinumab-ttwe as biosimilar for pediatric plaque psoriasis, active psoriatic arthritis. Contemporary Pediatrics. July 9, 2024. Accessed June 16, 2025. https://www.contemporarypediatrics.com/view/fda-approves-ustekinumab-ttwe-as-biosimilar-for-pediatric-plaque-psoriasis-active-psoriatic-arthritis