FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara

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FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara

JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.[1]

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.

"The approval of Steqeyma reflects Celltrion's continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn's disease, psoriasis, and psoriatic arthritis," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "Steqeyma is now the latest biologic in our immunology portfolio, joining Zymfentra® (infliximab-dyyb). Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the U.S. immunology market."

"Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," said Mark G. Lebwohl*, MD, Icahn School of Medicine at Mount Sinai, New York. "The approval of new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population."

Ustekinumab is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines that play an important role in inflammatory and immune responses. Celltrion Inc. had reached a settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson, granting a license entry date for Steqeyma in the United States in February 2025.

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.

    • 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 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. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. For more information, please visit: www.celltrionusa.com.

    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 that may constitute forward-looking statements, under pertinent securities laws.

    These statements may be 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's 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 with respect to 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, 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 forward-looking statements.

    Such risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as they relate to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.

    Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

    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 (2024)

    Source: Celltrion

    Posted : 2024-12-19 12:00

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