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Ustekinumab Biosimilar Launches in the US
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The launch of ustekinumab-stba following its FDA approval expands patient access to this therapy with a variety of indications.
Ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinumab (Stelara; Janssen Pharmaceuticals), has been launched in the US and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn disease (CD) and ulcerative colitis (UC) in adults.1 The launch follows the FDA approval of ustekinumab-stba in December 2024, granted for the same indications as its reference product, ustekinumab.2
Image credit: Ольга Тернавская | stock.adobe.com
"Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, said in a news release. "The approval of a new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affects more than 3% of the US adult population."2
As a human IL-12 and -23 antagonist, ustekinumab-stba is used to treat various immune-mediated diseases. The drug is administered through subcutaneous injections with 45 mg and 90 mg prefilled syringes, or through intravenous infusions, provided in a 130 mg vial. It is approved for all the same conditions as the reference product, including PsO, PsA, CD, and UC in adults, as well as PsO and PsA in children aged 6 and older.1
"Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients," Lebwohl said in a news release. "Biosimilars increase access to essential therapies, while maintaining the same high standards as the reference product. The availability of Steqeyma provides patients and health care providers a cost-effective alternative to manage chronic inflammatory diseases."1
The FDA approval for ustekinumab-stba was based on comprehensive evidence, from a Phase 3 study involving adults with moderate to severe PsO. This study focused on the change in the Psoriasis Area and Severity Index (PASI) to assess skin symptom improvement. The study's findings showed that ustekinumab-stba and ustekinumab, its reference product, exhibit high similarity and lack clinically significant differences in both safety and efficacy.1,2
With the launch of ustekinumab-stba, the drug is reported to be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of ustekinumab. The biosimilar is intended to improve patient access for the indicated treatment.1
"The introduction of Steqeyma in the US, as one of the first-wave biosimilars to Stelara, marks an important step in our ongoing efforts to expand patient access to high-quality biologic treatments," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release. "With this launch, we are expanding our immunology portfolio beyond TNF-alpha to include IL-12/23 inhibitors, offering more options for multiple immune-mediated diseases. To further enhance accessibility, Celltrion is actively collaborating with key pharmacy benefit managers to secure broader formulary coverage for Steqeyma."1
The launch of ustekinumab-stba, following its FDA approval, expands patient access to this important therapy, emphasizing the pharmacist’s role in biosimilar integration.1 This includes ensuring appropriate patient selection, providing patient education on administration and potential side effects, monitoring for adverse events, and collaborating with prescribers to optimize treatment outcomes.
REFERENCES
1. STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States. Celltrion. News release. March 13, 2025. Accessed March 20, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3811
2. U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab). Celltrion. News release. December 18, 2024. Accessed March 20, 2025. https://www.celltrionusa.com/board/newslist/29#:~:text=About%20STEQEYMA%C2%AE%20(ustekinumab%2Dstba,in%20a%20single%2Ddose%20vial.
