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
EcoOnline Recognised as a Leader in Verdantix Green Quadrant: EHS Software 2026 for Third Time21.9.2026 18:43:00 CEST | Press release
EcoOnline achieved highest score for Safety Management and ranked among the top three vendors for Chemicals Management, Training and Contractor Safety with Lone Worker Protection a key differentiator. EcoOnline, the global provider of software that transforms how organisations protect people and the planet, has been recognised for the third consecutive time as a Leader in the independent Verdantix Green Quadrant: EHS Software 2026 report, with market-leading strength in Safety Management. The assessment evaluated leading vendors of environmental, health and safety software vendors across a range of capabilities and customer buying signals. Verdantix recognised EcoOnline’s strength in the areas organisations rely on to protect workers every day: Safety Management, Chemicals Management, AI-enabled Training and Contractor Safety. It reflects the changing needs of EHS buyers, who are increasingly looking for integrated platforms that connect everyday safety with broader operational risk an
rhode Announces the Return of Limited Edition Favorites and New Exclusives at Sephora Across Europe and the U.K.21.9.2026 15:00:00 CEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber and part of e.l.f. Beauty (NYSE: ELF), has announced that two community-favorite Peptide Lip Tints and a new Sephora-exclusive bag will launch at Sephora across Europe and the U.K. to celebrate the brand’s launch into Sephora in Europe on September 30, 2026. These items will join the brand’s assortment of high-performance skincare and hybrid makeup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921199856/en/ rhode announces the return of limited edition favorites and new exclusives at Sephora across Europe and the U.K. To mark the occasion with Sephora across Europe and the U.K., rhode is offering early access to purchase fan-favorite, previously limited edition Peptide Lip Tint in Pretzel at Sephora in Europe and the U.K. on the brand’s launch date September 30, before the product joins rhode’s permanent assortment globally on rhodeskin.com on October 1 and at all r
Pierre Le Manh to Step Down as PMI President and CEO21.9.2026 14:45:00 CEST | Press release
Project Management Institute (PMI), the leading authority in project management, today announced that Pierre Le Manh has decided to step down as President and Chief Executive Officer, effective September 30, 2026. Johannes Heinlein, Chief Growth Officer, has been appointed Interim President & Chief Executive Officer of PMI, also effective September 30, 2026. Pierre Le Manh joined PMI in September 2022. During his four-year tenure, he led the development and execution of PMI’s current strategy, strengthened its leadership team, expanded its capabilities through acquisitions and partnerships, and positioned PMI for a profession being rapidly transformed by artificial intelligence and a greater focus on project success. “On behalf of the Board, I want to thank Pierre Le Manh for his leadership and his commitment to PMI,” said Ike Nwankwo, Chair of the PMI Board of Directors. “PMI has a clear strategy, a strong leadership team and significant momentum. Pierre leaves the organization well p
Lenovo and Schneider Electric Partner to Bring Decarbonization Tools and Expertise to IT Channel Partners21.9.2026 14:10:00 CEST | Press release
New partnership gives channel partners a practical pathway to measure emissions, build decarbonization roadmaps, and demonstrate sustainability progress Lenovo today announced that Schneider Electric, a global energy technology leader, will join Lenovo 360 Circle as a strategic ally to bring decarbonization expertise and management tools directly to IT channel partners. Lenovo 360 Circle is Lenovo’s global sustainability community, bringing together channel partners worldwide to collaborate on shared challenges, accelerate sustainability transformation, and turn sustainability ambitions into business opportunities. Through its Allyship program, Lenovo 360 Circle connects partners with leading technology and industry organizations to enable collaboration and provide access to specialized expertise that helps partners accelerate their sustainability goals. As its newest strategic ally, Schneider Electric will bring its Decarbonization Champion initiative to the community, giving eligible
Serbian Biotech Startup Takes Its Journey from Belgrade to Cambridge with Documentary on Longevity Science21.9.2026 13:02:00 CEST | Press release
BioEridan, a Serbian biotechnology company backed by Telekom Srbija Group’s TS Ventures Fund, has premiered a documentary charting its journey from an early scientific project in Belgrade to an emerging biotechnology venture focused on longevity research BioEridan, a Serbian biotechnology startup backed by Telekom Srbija Group’s TS Ventures Fund, has premiered a new documentary showcasing its development of underwater Aquafarms and its ambition to contribute to the next generation of longevity science. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921345879/en/ BioEridan Documentary Premiere BioEridan: Science Beneath the Surface premiered in Belgrade on September 15 before being screened the following day at a UK-Serbia Health, Digital Transformation & Innovation roundtable held at Christ’s College, University of Cambridge, as part of Cambridge Tech Week 2026. The roundtable brought together prominent representatives fr
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