Latest news with #Stoboclo
Korea Herald
10-04-2025
- Business
- Korea Herald
Celltrion wins 3 biosimilar approvals in Australia, eyes Oceania growth
South Korea's pharmaceutical giant Celltrion said Thursday it has received regulatory approvals for three biosimilars in Australia over the past two weeks, a move expected to amplify its presence in the Oceania market. According to the biosimilar maker, the approvals from Australia's Therapeutic Goods Administration cover eye treatment Eydenzelt, its version of Regeneron Pharmaceuticals' Eylea, as well as two bone-related therapies Stoboclo and Osenvelt, referencing Amgen's Prolia and Xgeva, respectively. With the newest additions, Celltrion now has 11 products either approved or marketed in Australia. 'Australia's biosimilar-friendly environment continues to spur our growth momentum,' a company official said. 'We aim to complete the remaining commercialization steps swiftly to ensure stable supply in the market.' Eydenzelt, available in both vial and prefilled syringe forms, has been approved for the treatment of myopic choroidal neovascularization, or CNV, making it the first biosimilar in its category to gain approval in Australia. Its reference product, Eylea, generated $9.52 billion in global sales last year, underlining strong market potential, the company noted. Stoboclo and Osenvelt were approved for all indications held by their reference biologics in Australia. Stoboclo is indicated for postmenopausal osteoporosis, while Osenvelt is approved for preventing skeletal-related events in cancer patients with bone metastases and for treating giant cell tumors of bone. Their originator drugs Prolia and Xgeva recorded a combined $6.59 billion in global sales last year. The company said the approvals mark a key milestone in expanding its global reach, including in the Oceania region, with additional plans to broaden its pipeline in ophthalmology and bone-related therapies.
Korea Herald
04-03-2025
- Business
- Korea Herald
Celltrion secures FDA approval for bone disease biosimilars
Celltrion announced Tuesday that its biosimilars Stoboclo and Osenvelt, referencing bone disease treatments Prolia and Xgeva (denosumab), have received marketing approval from the US Food and Drug Administration. Stoboclo is approved for treating postmenopausal osteoporosis in women, while Osenvelt is indicated for the prevention of skeletal-related complications in cancer patients with bone metastases and for giant cell tumors of bone. Both products have been approved for all indications covered by the original reference drugs in the US. Prolia and Xgeva recorded approximately $6.59 billion combined in global sales in 2023, with the US market alone accounting for two-thirds of that at $4.39 billion. Celltrion plans to launch Stoboclo and Osenvelt in the US market as early as this year, following the completion of a patent settlement agreement with the original drug developer. In November, Celltrion became the first company in Korea to obtain approval for these biosimilars, ahead of competing products. It also secured approval from the European Commission last month, accelerating its efforts to expand sales in major global markets. Celltrion has been making aggressive moves to broaden its treatment portfolio, gaining approval for biosimilars for autoimmune diseases, oncology, ophthalmology and bone disease across key global markets. So far this year, the company has obtained three product approvals in the US and four in Europe, totaling seven across both markets. The company last year already surpassed its goal of establishing an 11-product portfolio in Korea by 2025. It recently met the same goal in Europe. "Our recent approvals in major global markets reaffirm our in-house biosimilar development capabilities," a Celltrion official said. "We will focus on completing the remaining regulatory approvals for our pipeline products while ensuring the rapid market penetration of approved products to drive revenue growth."
Yahoo
24-02-2025
- Business
- Yahoo
Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars
Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU market European Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical data The company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030 INCHEON, South Korea, February 19, 2025--(BUSINESS WIRE)--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 TrialThe 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 TrialIn 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 CelltrionCelltrion 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 and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain 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 and Xgeva® are registered trademarks of Amgen Inc. Eydenzelt® is a registered trademark of Celltrion 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: [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: [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: [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 Contacts Donna Gandhidgandhi@ +44 (0) 7827 053 502
