- 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, NJ, USA I March 12, 2025 I 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.
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.
References
[1] STEQEYMA U.S. prescribing information (2024)
[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/s40259-023-00630-5#article-info [Last accessed February 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 February 2025]
SOURCE: Celltrion
Post Views: 128
- 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, NJ, USA I March 12, 2025 I 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.
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.
References
[1] STEQEYMA U.S. prescribing information (2024)
[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/s40259-023-00630-5#article-info [Last accessed February 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 February 2025]
SOURCE: Celltrion
Post Views: 128
