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
Rubedo’s RLS-1496 Reduces Actinic Keratosis Pre-Cancerous Skin Lesions by 46% at Four Weeks with Minimal Irritation in Preliminary Results of Phase 1b/2a Study28.5.2026 14:30:00 CEST | Press release
RLS-1496 is an investigational, first-in-class, disease-modifying, selective glutathione peroxidase 4 (GPX4) modulator that targets pathologic senescent and other stressed, aging cells that drive chronic, age-dependent diseases, such as AK, and represents a novel drug category — Adaptive SenoTherapeutics In recognition of May as Skin Cancer Awareness Month, Rubedo is calling attention to the myths and facts surrounding AKs — and to the urgent need for a new generation of treatments that are effective without the side-effect burden of today's options Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on selective cellular rejuvenation medicines targeting aging cells, today announced preliminary results from a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis (AK), a common age-related condition resulting in precancerous skin lesions, that is most commonly seen after age 65.1 The open-label multi-center trial, conducted in the United States,
ExaGrid Wins 5 Industry Awards at Network Computing Awards 202628.5.2026 14:00:00 CEST | Press release
ExaGrid named “Company of the Year” for seventh year in a row ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the most Comprehensive Security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that company was honored with five industry awards, including Air-gapped Ransomware Recovery Product of the Year, Bench Tested Product of the Year, Company of the Year, Data Protection Product of the Year, and the Storage Product of the Year during the Network Computing Awards ceremony, held in London on May 21, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528849813/en/ The ExaGrid team headed to the stage five times throughout the Network Computing Awards ceremony in London to accept awards for ExaGrid Tiered Backup Storage. Photo courtesy of Network Computing Awards. The Network Computing Awards are determined by public vote. The 2026 awards mark
Ardoq Launches AI-First Enterprise Architecture Platform28.5.2026 14:00:00 CEST | Press release
Custom Agents, Omnipresent AI Assistant, and AI Import Builder Automate an Estimated 40% of Routine EA Work; Tenneco Already Achieving 292% ROI on Ardoq AI Ardoq, named a 5x Leader in the Gartner® Magic Quadrant™ for Enterprise Architecture Tools, today launched its AI-first enterprise architecture (EA) platform. The release grounds every Ardoq AI output in customers' live architecture data and introduces a new generation of AI agents capable of automating an estimated 40% of routine EA work. Architects today are being asked to defend decisions that generic AI is generating in seconds. Application rationalization choices. ERP transformation roadmaps. AI governance reviews. The questions land on the architect's desk, but the analysis underneath increasingly comes from AI assistants that do not know the architecture. Generic agents reason on whatever document is in front of them, not on the live relationships between applications, dependencies, capabilities, and risks. Ask a generic LLM
European DataWarehouse Launches DealDox®, a Next-Generation Virtual Data Room Built specifically for the Securitisation Market28.5.2026 14:00:00 CEST | Press release
European DataWarehouse (EDW) announced today the launch of DealDox®, a secure virtual data room uniquely tailored to the needs of the securitisation and structured finance market. Developed in response to long‑standing challenges around transaction data and document management, DealDox provides a single, secure environment where all parties throughout the deal lifecycle can collaborate efficiently while maintaining high standards of security, governance, and regulatory alignment. DealDox enables the centralised management of transaction data and documentation, offering robust security, granular access controls, and clear audit trails. The platform integrates seamlessly with EDW’s existing regulatory reporting ecosystem, supporting smoother workflows from deal preparation through to disclosure and compliance. “As a market infrastructure, our role is to reduce complexity and make processes simpler and more transparent for all participants,” said Dr. Christian Thun, CEO of European DataWa
SLB and Vår Energi Expand Digital Collaboration to Scale Well and Integrated Field Development Planning28.5.2026 13:47:00 CEST | Press release
Agreement supports Vår Energi’s ambition to reduce time to first oil, building on multi-discipline, collaborative well planning workflows that reduce cycle times from months to days Global energy technology company SLB (NYSE: SLB) today announced an expanded collaboration with Vår Energi to scale well planning and integrated field development planning across its Norwegian Continental Shelf operations. With collaborative well planning already reducing cycle times from months to days and integrated field development planning expected to support similar benefits, the expanded deployment is designed to support faster, more consistent decision-making as operators work to sustain production from mature offshore assets while managing increasing development complexity. As part of the expanded collaboration, Vår Energi is deploying the Delfi™ digital platform to connect exploration, subsurface evaluation, well planning, subsea design, field development planning, and production in a cloud-native
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