Celltrion

• STEQEYMA^® (ustekinumab-stba) is Celltrion's biosimilar to STELARA^® (ustekinumab), which was launched on March 12, 2025

• Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024

   

JERSEY CITY, N.J., March 27, 2025 - Celltrion, Inc., today announced that STEQEYMA^® (ustekinumab-stba), a biosimilar to STELARA^® (ustekinumab) has been added to the Costco Member Prescription Program.

"We're focused on improving affordability and access to a widely used, high-cost treatment for a variety of inflammatory conditions," said Francine Galante, Vice President of Market Access at Celltrion USA. "The addition of STEQEYMA to the Costco Member Prescription Program together with adalimumab-aaty will help us deliver our commitment to lowering financial barriers and improving access to critical treatments."

STEQEYMA is available in both subcutaneous injection and intravenous infusion and 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.

The Costco Member Prescription Program is a prescription drug discount card program offered by Costco Health Solutions that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on STEQEYMA and other participating drugs at Costco Specialty Pharmacies and at participating pharmacies. 

"By partnering with Costco Health Solutions once again, we are able to help even more Americans lower the price of their prescriptions, given the fact that Stelara ranks as one of the most expensive prescription drugs on the market," said Tom Nusbickel, Chief Commercial Officer at Celltrion USA.

STEQEYMA will be available in the U.S. from Costco Specialty Pharmacies on April 1^st, 2025, for self-funded employer plans and Costco members who are uninsured and want to pay cash for their STEQEYMA prescription or who have been denied coverage by their insurers.

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 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.
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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 develops, 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
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 ten biosimilars approved by the U.S. FDA: 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 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.

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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.