FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA

The FDA approved ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to Stelara (ustekinumab; Janssen Pharmaceuticals), for the treatment of plaque psoriasis (PsO) or psoriatic arthritis (PsA) in pediatric patients aged 6 to 17 years who weigh less than 60 kg. The biosimilar is a 45 mg/0.5 mL single-dose vial that is administered via a subcutaneous infusion.¹

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Both PsO and PsA are chronic autoimmune diseases that are characterized by thick, scaly patches on the skin. Although PsO typically affects the elbows, back, knees, and scalp, severe cases can impact other areas of the body, including the face, feet, genitals, hands, and legs. PsA is localized to the joints and oftentimes the fingers and toes. Symptoms of these conditions can be treated with nonsteroidal anti-inflammatory medicines, corticosteroids, and immunosuppressive medicines, as well as vitamins and minerals. Lifestyle modifications that may also relieve symptoms include exercise, applying heat or cold to the affected areas, and occupational and/or physical therapy.^2,3

Steqeyma, which was formerly known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. In December 2024, the FDA approved the biosimilar in 45-mg/0.5 mL and 90-mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection. Additionally, 130 mg/26 mL single-dose vials for intravenous infusion were approved in both adult and pediatric patients aged 6 years and older with PsO and PsA, as well as adult patients with Crohn disease and ulcerative colitis.^1,4

The FDA approval of Steqeyma was based on the totality of evidence, including results from a randomized, active-controlled, double-blind phase 3 clinical trial (NCT04673786) that assessed whether the biosimilar’s efficacy and safety were similar to its reference product in patients with moderate to severe PsO. In the first treatment period, 509 patients were randomly assigned to receive the biosimilar (n = 256) or originator product (n = 253). The findings indicated that the mean percent improvement in Psoriasis Area Severity Index scores at week 12 were 77.93% and 75.89%, respectively. Estimated treatment differences were about 2.05 (90% CI −0.23, 4.32). Additionally, further efficacy parameters as well as pharmacokinetic, safety, and immunogenicity outcomes were comparable between the treatment groups, including after switching from the reference ustekinumab to the biosimilar.^1,4-6

"Managing inflammatory diseases in pediatric patients can be particularly complex," Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA, said in a news release. "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."¹

The most common adverse events (AEs) reported by patients were nasopharyngitis, upper respiratory infection, and headache in PsO; vomiting, nasopharyngitis, infection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis in Crohn disease; and nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea in ulcerative colitis.^1,4

"We are proud to offer a new presentation of Steeyma that aligns with the indications of the reference product," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the news release. "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."¹

REFERENCES

1. PR Newswire. Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients. News release. June 15, 2025. Accessed June 16, 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. Cleveland Clinic. Plaque Psoriasis. Accessed June 16, 2025. https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis

3. Johns Hopkins Medicine. Psoriatic Arthritis. Accessed June 16, 2025. https://www.hopkinsmedicine.org/health/conditions-and-diseases/arthritis/psoriatic-arthritis

4. Celltrion. STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States. News release. March 12, 2025. Accessed June 16, 2025. https://www.celltrionusa.com/board/newslist/34

5. Ferruggia K. Ustekinumab Biosimilar Launches in the US. Pharmacy Times. March 20, 2025. Accessed June 16, 2025. https://www.pharmacytimes.com/view/ustekinumab-biosimilar-launches-in-the-us

6. 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 Randomised, Active-Controlled, Double-Blind, Phase III Study. BioDrugs 2024;38:121–131. doi:10.1007/s40259-023-00630-5