STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States

• STEQEYMA^®, one of the first-wave biosimilars to STELARA^®, is now available in the U.S.
• Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments^[1]
• With the launch of STEQEYMA, Celltrion expands its immunology portfolio beyond tumor necrosis factor (TNF)-alpha inhibitors, to include interleukin (IL)-12 and IL-23 inhibitors, broadening treatment options for multiple immune-mediated diseases
• Celltrion has nine biosimilars and five immunology biologics granted marketing authorization in the U.S.

JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Celltrion today announced the U.S. launch of STEQEYMA^® (ustekinumab-stba), a biosimilar to STELARA^® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024. STEQEYMA is approved for the same indications as STELARA, providing consistency in treatment for patients and healthcare providers.^[1]

STEQEYMA is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion.^[1]

"Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients," said Mark G. Lebwohl*, MD, Icahn School of Medicine at Mount Sinai, New York. "Biosimilars increase access to essential therapies, while maintaining the same high standards as the reference product. The availability of STEQEYMA provides patients and healthcare providers a cost-effective alternative to manage chronic inflammatory diseases."

STEQEYMA will be priced with a WAC list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments.

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 introduction of STEQEYMA in the U.S., 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," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "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."

STEQEYMA is supported by Celltrion's comprehensive patient and practice support programs, designed to assist patients throughout their treatment journey. Celltrion offers a suite of resources, including Celltrion CONNECT^® Patient Support Program and Celltrion CARES™ Co-pay Assistance Program, benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose. Patients who are uninsured may be eligible to receive STEQEYMA through the Celltrion CONNECT^® Patient Assistance Program (PAP). Additionally, nurses will be available to answer patient questions and provide injection support. Visit www.CelltrionConnect.com to learn more.

Celltrion has nine biosimilars approved by the FDA, demonstrating its established leadership in the biosimilar development space and its commitment to advancing high-quality treatments. STEQEYMA has also received approval in key global markets, including the European Union, Canada and Australia. 

Notes to Editors:

*Dr. Mark Lebwohl is a paid consultant for Celltrion.

About STEQEYMA^® (ustekinumab-stba)

STEQEYMA^®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA^® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.

INDICATIONS

STEQEYMA^® (ustekinumab-stba) is indicated for the treatment of:

• Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease.
• Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis.

IMPORTANT SAFETY INFORMATION

• STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA. 
• Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves.
• Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances.
• Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA.
• Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies.
• If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA.
• If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA.
• Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease.
• If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment.
• The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:
  • Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  • CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
  • UC: nasopharyngitis, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.

For more information, see Full Prescribing Information.

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook.

About Celltrion USA

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilars approved by the U.S. FDA: INFLECTRA^® (infliximab-dyyb), TRUXIMA^® (rituximab-abbs), HERZUMA^® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA^®(adalimumab-aaty), STEQEYMA^® (ustekinumab-stba), AVTOZMA^® (tocilizumab-anoh), OSENVELT^®/ STOBOCLO^® (denosumab-bmwo), and OMLYCLO^® (omalizumab-igec), as well as a novel biologic ZYMFENTRA^® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control.

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Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Trademarks

STELARA^® is a registered trademark of Johnson & Johnson.
STEQEYMA^® is a registered trademark of Celltrion, Inc., used under license.

References

For further information please contact: 
Andria Arena
[email protected]
+1 516-578-0057

SOURCE Celltrion