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
SymphonyAI Brings AI-Powered Assortment and Space Platform to Global CPGs, Compressing Category Review Cycles from Weeks to Days2.6.2026 00:35:00 CEST | Press release
CINDE Assortment and Space closes the loop between assortment, planogram, and in-store execution, proven across 500-plus global CPG deployments Planogram compliance failures, undetected out-of-stocks, and the lag between headquarters planning and store-level execution cost grocers measurably in comp sales, shrink, and associate labor hours. The tools built for category planning have never been designed to close that execution gap. In response, SymphonyAI, a global leader in Vertical AI, today announced the availability of CINDE Assortment and Space for CPGs, an AI platform that closes the loop between assortment strategy, planogram execution, and in-store compliance, compressing the category review cycle from four to six weeks to a matter of days. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602137061/en/ The platform is underpinned by SymphonyAI's Transferable Demand AI, a model trained across 25 years of retail data a
SymphonyAI Launches CINDE Retail Media Intelligence to Connect Merchandising and Media for Mid-to-Large Grocers2.6.2026 00:05:00 CEST | Press release
CINDE RMI connects merchandising and retail media in a single closed-loop platform — without replacing your existing retail media stack Retail media has become the fastest-growing profit line in grocery, yet the billions of dollars CPG advertisers invest in it every year flow through a system where media buyers and merchants never see the same data. Merchants plan assortments, negotiate trade spend, and execute resets with no visibility into which CPG media investments are driving category velocity, while CPG advertisers renew or walk based on incrementality proof that most retailers cannot provide. To solve for this, SymphonyAI, a global leader in Vertical AI, today announced the general availability of CINDE Retail Media Intelligence (RMI), an AI platform that connects merchandising, media, and shopper intelligence into a single closed-loop system, giving retailers and CPG partners shared visibility into how every media dollar moves category turns, trade spend ROI, and gross margin a
SES Launches Multi-Orbit Satellite Connectivity on Mexico’s Viva1.6.2026 20:00:00 CEST | Press release
SES, a leading space solutions company, and Viva, Mexico’s ultra low-cost airline, launched fast and reliable multi-orbit satellite inflight connectivity service on Viva’s Airbus aircraft, strengthening SES’s position as a leading provider of satellite-powered broadband inflight service in the Americas and around the world. “Viva’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’ partnerships with growing airlines like Viva highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is the engine that powers inflight connectivity, a trusted partner that makes airline operations easier,” said Mike DeMarco, SES President of Mobility. A total of 60 A320s and 40 A321s are set to offer the SES solution in the coming years. With the youngest Latin American fleet of Airbus A320s and A3
Motive Powers Latin America’s Next Wave of Mobile Innovation1.6.2026 17:00:00 CEST | Press release
Motive Entitlement Server enabling satellite connectivity in the Andes to fraud-free authentication in Brazil Motive, a global leader in entitlement and connected device & service management, joined operators and industry leaders at M360 LATAM in Mexico City, showcasing live deployments across the region's most consequential use cases: Satellite Direct-to-Device connectivity for unreachable geographies, end-to-end eSIM provisioning and visibility at scale, and SIM-based silent authentication replacing fraud-exposed SMS OTP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260531906729/en/ Across landmark deployments with multiple Claro, Vivo, and Entel operations, Motive’s Entitlement Server (Motive ES) has moved from infrastructure component to regional growth engine. These deployments are citing measurable commercial growth, enabling streamlined eSIM provisioning, improved device onboarding experiences, and new revenue oppor
Interactive Brokers Integrates AI into Client Portfolios – Informed by Agentic Technology, Controlled by the Client1.6.2026 16:00:00 CEST | Press release
Clients Can Research Stocks, Analyze Performance, and Generate Trade Instructions in Claude. The Client Approves Every Trade. Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced agentic trading through direct integration with Claude, one of the world's leading AI platforms. Available through the AI platform’s certified connector marketplace, the integration lets clients manage their accounts and access more than 170 global markets. "Interactive Brokers has used technology for over four decades to help investors make more informed decisions and interact more efficiently with markets," said Milan Galik, Chief Executive Officer of Interactive Brokers. "Investors are increasingly using artificial intelligence to research markets, analyze information and generate ideas. We believe the next logical step is to allow clients to securely connect AI tools directly to their brokerage accounts — whether they want a simple conversational interface, deeper portfolio analy
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