- Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg
- The FDA previously approved STEQEYMA® 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
- STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA®
INCHEON, South Korea, June 15, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).[1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients.
In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.
"Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "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."
"We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "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."
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 FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.
Notes to Editors:
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 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. 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, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
For more information, see Full Prescribing Information.
About Celltrion, Inc.
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's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the 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", "anticipate" 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.
Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
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
[1] STEQEYMA U.S. prescribing information (2025) |
[2] Papp KA 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. 2023; Online ahead of print. Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5article-info [Last accessed June 2025] |
[3] Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CTP43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf [Last accessed June 2025] |
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Andria Arena
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SOURCE Celltrion
