Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars
Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® (CT-P42, aflibercept), a biosimilar to Eylea® to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo® and Osenvelt® (CT-P41, denosumab), biosimilars referencing Prolia® and Xgeva® used for all indications of the reference products. The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology.
“Celltrion is committed to expanding access to high-quality monoclonal antibody treatments for patients across Europe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Securing regulatory approval for three biosimilar products on the same day highlights our commitment to providing healthcare professionals with reliable, effective, and accessible treatment options for their patients. With a portfolio of 11 biosimilar brands and a fully integrated approach—from research and development to manufacturing and direct supply—Celltrion is increasing treatment options, improving patient access to biologics, and strengthening its role as a trusted partner for healthcare professionals in Europe, all while supporting the sustainability of healthcare systems.”
Data showed that Eydenzelt®(40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo® (60 mg solution for injection in pre-filled syringe) and Osenvelt® (120 mg solution for injection in vial) have comparable quality, safety and efficacy when compared to their respective reference products, Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab), respectively. 1,2,3
“The European Commission approval of Eydenzelt®, Stoboclo® and Osenvelt®are a significant milestone and a welcome addition to our portfolio of medicines to address a significant unmet need in therapeutic areas including skeletal-related disorders and ophthalmology,” said Min Kyoung Jeon, Vice President and Head of Regulatory Affairs Division at Celltrion. “The approval highlights Celltrion’s continuous commitment to expanding the availability, access and uptake of these important treatment options to patients with unmet needs.”
The company’s therapeutics include a total of 11 biosimilar products: 4 immunology products, including Remsima®/Inflectra® (US), Remsima® SC, Yuflyma®, and SteQeyma®; 3 oncology products, including Truxima®, Herzuma®, and Vegzelma®; and other therapeutic areas, including Omlyclo®, Eydenzelt®, Stoboclo® and Osenvelt®.
About CT-P41 Phase III Clinical Trial
The Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Results of the study showed that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab, with similar pharmacokinetic and comparable safety and immunogenicity profiles.3
About CT-P42 Phase III Clinical Trial
In a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt® was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). Results of the study showed that Eydenzelt® met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea®.1,2
About Stoboclo® (CT-P41, biosimilar denosumab)
Stoboclo® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia® (denosumab). In Europe, Stoboclo® has been approved to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.4 Stoboclo® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA).
About Osenvelt® (CT-P41, biosimilar denosumab)
Osenvelt® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva® (denosumab). Osenvelt® has been approved in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.5 Osenvelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA).
About Eydenzelt® (CT-P42, biosimilar aflibercept)
Eydenzelt® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea®3, Eydenzelt® is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV).6 Eydenzelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA).
About Celltrion
Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.
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 results expressed or implied by such forward-looking 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.
Trademarks
Stoboclo® and Osenvelt® are registered trademarks of Celltrion Inc.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
Eydenzelt® is a registered trademark of Celltrion Inc.
Eylea® is a registered trademark of Bayer AG.
References
_____________________________________
1 Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed February 2025].
2 Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed February 2025].
3 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed February 2025].
4 European Medicines Agency Summary of Product Characteristics (SmPC), Stoboclo. [Last accessed February 2025].
5 European Medicines Agency Summary of Product Characteristics (SmPC), Osenvelt. [Last accessed February 2025].
6 European Medicines Agency Summary of Product Characteristics (SmPC), Eydenzelt. [Last accessed February 2025].
View source version on businesswire.com: https://www.businesswire.com/news/home/20250206269326/en/
Contacts
Donna Gandhi
dgandhi@hanovercomms.com
+44 (0) 7827 053 502
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
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
Astronauts’ Health During Space Missions: Nichi BRITE and Neu REFIX Beta Glucans Could Benefit by Neutrophil-to-Lymphocyte Ratio, IL-6 Control, the Immune Biomarkers of Aging and Longevity17.3.2025 11:22:00 EET | Press release
Neutrophil to Lymphocyte ratio (NLR) is a critical biomarker of health of astronauts during space mission, and that of aging related illnesses, inflammaging, longevity and cancer prognosis. Oral consumption of AFO-202 strain of Aureobasidium pullulans produced Nichi BRITE and N-163 strain produced Neu REFIX together in pre-clinical and clinical studies having safely and beneficially modified NLR, are considered holding potential to help maintain astronauts health during space flight and also to bridge the gap between health span and life span by ‘Me-Byo’ phenomenon as published in Frontiers in Immunology while Neu REFIX standalone yielding enhanced dystrophin, an additional benefit that might help prevent muscle loss during space missions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250316966059/en/ Astronauts during space missions, deep-sea researchers, high-altitude climbers, and workers exposed to radiation hazards, ar
Cineca to House Italy’s Most Powerful Quantum Computer IQM Radiance 5417.3.2025 11:04:00 EET | Press release
Italian supercomputing centre Cineca today announced an agreement with IQM Quantum Computers, a global leader in superconducting quantum computers, to deliver the most powerful quantum computer in Italy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250317715500/en/ IQM Radiance 54-qubit superconducting quantum computer IQM Radiance quantum computer, powered by IQM’s 54-qubit quantum processing unit (QPU), will be installed in the fourth quarter of 2025. The quantum computer will be integrated into Leonardo, which is one of the world’s fastest supercomputers. This will mark a major technology and innovation milestone for Italy and the larger quantum ecosystem. The installation will also be the first on-premises quantum computer at Cineca, which further consolidates the institution’s position as a centre of excellence for scientific computing internationally and strengthens Italy’s position in quantum computing. IQM intends
Alipay+ Empowers New Growth Opportunities for Malaysian SMEs, Contributing More Than 80% of Inbound QR Payments via DuitNow17.3.2025 10:00:00 EET | Press release
In their first full year of partnership in 2024, Payments Network Malaysia Sdn Bhd (PayNet) and Ant International, a leading global digital payment, digitisation and financial technology provider, brought new economic opportunities to Malaysian SMEs, with Alipay+ making up more than 80 percent of cross-border inbound QR payments via DuitNow. In the peak travel season in December 2024, the partnership enabled 6 times growth in revenue for Malaysian merchants, compared to the same period in 2023. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250317987292/en/ Malaysian SMEs can connect with global customers via DuitNow QR and Alipay+ In October 2023, Alipay+, a unified wallet gateway with cross-border payment and digitisation services under Ant International, went live on DuitNow QR, enabling Malaysian SMEs to accept QR payments from international travellers. Today, the number of Alipay+ payment partners that can make payment
NTT DATA and CrowdStrike Expand Partnership to Strengthen AI-Powered Cyber Resilience17.3.2025 10:00:00 EET | Press release
NTT DATA, a global digital business and IT services leader, and CrowdStrike, a global cybersecurity leader, today announced an expanded partnership to power NTT DATA's managed cybersecurity services with the AI-native CrowdStrike Falcon® cybersecurity platform. Cyberattacks are growing faster, stealthier and more sophisticated, while the cybersecurity skills gap leaves organizations vulnerable. To protect against modern threats, clients need AI-native platform technology and the benefits of a managed security solution to reduce complexity and serve as a force multiplier for security and IT teams. By combining NTT DATA’s world-class managed services with the power of the Falcon platform, clients gain the protection they need to stop breaches. Key capabilities of the partnership include: Integrated Managed Security Services: The integration of the Falcon platform with NTT DATA’s managed services provides organizations with advanced threat detection and response across their digital envir
Appaloosa Statement Regarding SES Announcement17.3.2025 10:00:00 EET | Press release
Appaloosa LP (“Appaloosa”), which manages funds holding a more than 7% economic interest in SES S.A. (“SES” or the “Company”), today issued the following statement in response to the SES Board of Directors’ (the “Board”) March 14, 2025 announcement. “The satellite industry is evolving rapidly and, as the SES Board’s announcement makes clear, even glacial change at SES requires strong shareholder advocacy. The initial steps the SES Board is taking to modernize its structure are long-overdue and only came following shareholder pressure. However, much more can, and must, be done -- with a greater sense of urgency than is evident from the Board’s incrementalism. “Specifically, adding a director with capital markets experience should be a priority as we believe such an appointment could prompt SES to finally begin addressing its underperforming capital investment practices and return value to shareholders. Likewise, the remaining board, capital structure and governance measures outlined in
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