CELLTRION
26.8.2024 00:58:33 CEST | Business Wire | Press release
Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar referencing Stelara®, for the treatment of multiple chronic inflammatory diseases. SteQeyma is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications.1 Stelara was the first biologic therapy for Crohn’s disease to target interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses.2
The decision from the EC follows a positive opinion recommending SteQeyma from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.3
The EC 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 is highly similar to its reference product, Stelara, and has no clinically meaningful differences in terms of efficacy and safety.4,5
“The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases,” said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion. “This approval, alongside those of Remsima SC and Yuflyma, marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector. We believe the approval demonstrates our unwavering commitment to expanding patient access to affordable, high-quality biologic medicines.”
SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU). Alongside Remsima® SC, a subcutaneous formulation of infliximab approved in the EU, SteQeyma joins Celltrion’s distinguished portfolio that includes Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), Vegzelma® (biosimilar bevacizumab) and Omlyclo® (biosimilar omalizumab).
About SteQeyma® (CT-P43, biosimilar ustekinumab)1
SteQeyma®, formerly known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. 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.
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma®, Yuflyma® and Omlyclo®, FDA approval for Zymfentra®, and EC approval for Remsima® SC. To learn more, please visit www.celltrion.com/en-us.
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.
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 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, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries 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 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. The reader is cautioned not to place undue reliance on forward-looking statements.
Trademark
Stelara® is a registered trademark of Johnson & Johnson.
SteQeyma® is a registered trademark of Celltrion, Inc., used under license.
References
1 European Medicines Agency Summary of Product Characteristics (SmPC), SteQeyma.
2 European Medicines Agency. Summary of Product Characteristics (SmPC), STELARA Available at: https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf. [Last accessed August 2024].
3 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024. [Last accessed August 2024].
4 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; Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5. [Last accessed August 2024].
5 Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CT-P43 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 August 2024].
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240819920486/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Vena Completes Acterys Acquisition to Accelerate Orchestrated Planning for the Microsoft Ecosystem26.3.2026 14:00:00 CET | Press release
The combination connects AI-driven financial and operational planning, analytics and execution across Microsoft Excel and Power BI, removing decision latency for Microsoft-centric enterprises. Vena, the AI-powered Orchestrated Performance Management platform purpose-built to fully amplify the Microsoft technology ecosystem, today announced it has completed its acquisition of Acterys, the leading Microsoft Power BI–based operational planning and app development platform. The move strengthens Vena’s Orchestrated Planning solution and begins phased integration of the two platforms. Modern enterprises are struggling to keep up with the volatility and dynamism of the markets they serve. Market drivers and signals shift rapidly, and the ability to assess, plan and execute with confidence and speed is more important than ever. These forces, combined with overwhelming data density and disparity, have created a new constraint: decision latency—the time between signal and action. As that gap wid
Nearly Half of Global C-Suites Plan U.S. Expansion Within 12 Months, as Supply Chain and Capital Access Drive Growth26.3.2026 14:00:00 CET | Press release
• 45% of C-level executives plan to establish a U.S. legal entity within the next 12 months; a further 27% say they will consider entry within two to three years • 65% cite supply chain or manufacturing efficiency as the primary driver for U.S. expansion • 88% identify federal and state tax reporting as the most burdensome area of U.S. compliance Nearly half (45%) of global C-suite leaders plan to establish a legal entity in the United States within the next 12 months, highlighting continued demand for access to the U.S. market. This finding from the latest research by CSC—the leading provider of global business administration and compliance solutions—demonstrates the U.S. continues to attract investment from around the world, even as companies face an increasingly complex regulatory landscape. CSC surveyed 300 C-level executives at large organizations headquartered in Europe, the U.K., Asia Pacific, and South America to examine global sentiment toward U.S. market entry, including expa
Lone Star Funds Completes Acquisition of Alliance Ground International26.3.2026 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has completed the acquisition of Alliance Ground International (“AGI”), a leading North American airport services provider. “We are excited to partner with the AGI management team to drive the business forward,” said Donald Quintin, Chief Executive Officer of Lone Star. “The company has a superior service offering and a track record of success across its integrated operations. We see opportunities to continue to invest in the business and its people to continue to grow its capabilities and ensure it remains best-in-class in delivering for the aviation industry.” “Today marks an important next step for AGI as we move forward in partnership with Lone Star,” said Jared Azcuy, Chief Executive Officer of AGI. “Our commitment to safety, reliability, and operational service excellence remains unchanged. This partnership strengthens our ability to deliver for our airline partners and reinforces that the
Rubedo Life Sciences Announces Positive Preliminary Phase 1 Clinical Trial Results for Lead Drug Candidate RLS-1496 in Patients with Plaque Psoriasis, Atopic Dermatitis, and Skin Aging26.3.2026 13:30:00 CET | Press release
The Phase 1 study of RLS-1496, the first human trial of a GPX4 (selective glutathione peroxidase 4) modulator, met its primary endpoint and also demonstrated a statistically significant relationship between target engagement and clinical improvement in psoriasis and atopic dermatitis RLS-1496 is a first-in-class disease-modifying mechanism targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases of aging A second study for RLS-1496 – a Phase 1b/2a study in actinic keratosis (precancerous skin lesions) – is underway in the United States, with completion expected later this year Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, to moderate panel on senescence and skin at the Dermatology Innovation Forum (DIF) during the American Academy of Dermatology (AAD) annual meeting on Thursday, March 26, at 1:05 pm MT in Denver Oral presentation of data accepted at the Society for Investigative Dermatology (SID) from May 13-16, 2026, in Chicago Rubedo L
GE HealthCare announces lead industrial role in largest EU-funded IHI consortium to advance cardio-oncology care across Europe26.3.2026 13:30:00 CET | Press release
COMPASS is one of the largest public‑private partnerships under the European Union’s (EU) Innovative Health Initiative (IHI). The consortium aims to advance early detection and prediction of cardiotoxicity in cancer patients and cancer survivors. The initiative will leverage AI, advanced imaging, biomarkers, and integrated care pathways. GE HealthCare (Nasdaq: GEHC) today announced its leading industrial role in the new COMPASS consortium, a five-year initiative focused on improving precision cardio-oncology care and advancing early detection of cardiovascular risks in cancer patients across Europe. COMPASS combines clinical excellence with novel healthcare technology, and with a total budget of €50.5 million and more than sixty partners, it is one of the largest public-private partnerships under the IHI. Cardiovascular diseases are rising sharply among cancer patients and survivors, driven both by the increasing prevalence of pre‑existing cardiovascular conditions at diagnosis and by
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom