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
Xsolla Expands Its Community Management Tools for Creators, Community Leaders, and Resellers26.5.2026 15:00:00 CEST | Press release
Xsolla Adds New Features For Creators, Community Leader Experience, And Distinct Channels For Emerging Markets Xsolla, a leading global video game commerce company, today announced three simultaneous expansions of its community management tools and products. As the creator economy continues to reshape how games are discovered and the industry accelerates its shift toward direct-to-consumer commerce, Xsolla is building on its community management tools for creators, community leaders, and emerging markets, and will showcase them at TwitchCon Rotterdam later this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526596720/en/ Graphic: Xsolla The games industry has never had a shortage of people who drive player acquisition, loyalty, and commerce; it's had a shortage of infrastructure that recognizes them. Creators stream it. Community leaders build a culture around it. Local resellers get it into the hands of players in
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure26.5.2026 14:00:00 CEST | Press release
First commercial femtosecond laser image-guided, high precision trabeculotomy (FLIGHT) treatments mark a new era in interventional glaucoma; one where precision, safety, and the patient experience define the new standard of care ViaLase, Inc., a commercial stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today announced the successful completion of the first commercial FLIGHT procedures performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD. The first commercial FLIGHT procedures were performed using the ViaLuxe® Laser System to deliver an incision-free, image-guided femtosecond laser treatment designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce intraocular pressure in patients with open-angle glaucoma. “Centre for Sight has always been committed to bringing meaningful inno
BioIVT to Spotlight ADME-Tox Expertise and Solutions at Summer 2026 Events26.5.2026 14:00:00 CEST | Press release
Company will demonstrate how high-quality, well-characterized biospecimens are critical to the success of both new approach methodologies (NAMs) and traditional studies BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced it will showcase its broad portfolio of ADME-Tox solutions and research expertise at several leading industry events, including the 2026 MPS World Summit and the ISSX 16th European Meeting. The MPS World Summit takes place May 26-May 29, 2026, in Washington, D.C. BioIVT colleagues will be available at booth #115 to discuss research questions and needs, including preparation, handling, and utilization of the high-quality tissues and cells needed for microphysiological systems (MPS), as well as conducting ADME studies and bioanalysis. BioIVT offers an extensive range of control and disease state biospecimens, including SPHEROID CERTIFIED™ Hepatocytes as well as advanced HEPATOPAC® co-cultures
IHS Towers Publishes 2025 Sustainability Report26.5.2026 12:34:00 CEST | Press release
IHS Holding Limited (NYSE: IHS) (“IHS Towers”) group, one of the largest independent owners, operators, and developers of shared communications infrastructure in the world by tower count, has today published its 2025 Sustainability Report. The report covers sustainability activities from January 1, 2025 to December 31, 2025 and demonstrates IHS Towers’ continued commitment to its stakeholders, including, but not limited to, its employees, customers, suppliers, local communities, regulators, governments and shareholders. IHS Towers’ vision is to help create a connected world, where mobile connectivity promotes continued economic growth and social development. The communications infrastructure it provides is vital to enabling that connectivity. In 2025, IHS Towers continued to advance its four-pillar sustainability strategy – focusing on ethics and governance, environment and climate change, education and economic growth, our people and communities – as detailed in this report. Sam Darwi
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