Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
16.2.2025 00:00:00 CET | Business Wire | Press release
OBODENCE™ and XBRYK™ approved by the European Commission (EC) for all indications referencing Prolia and Xgeva, respectivelyMarks Samsung Bioepis’ 10th and 11th product and first endocrinology treatment approved by the EC – adding to its growing portfolio of biosimilars
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe) and XBRYK™ (120mg vial), denosumab biosimilars referencing Prolia and Xgeva – formerly referred to as SB16.
OBODENCE, referencing Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
XBRYK, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of 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.
Osteoporosis is a major concern in Europe as it results in 4.3 million fragility fractures and health care costs in excess of €56 billion annually. Less than half of women at high risk of fracture are treated despite the high cost of fractures and the availability of affordable medications.1 In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life.2
The EC approval was based on totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, and maximum serum concentration.3 In addition, a randomized, double-blind, multi-center Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.4,5
OBODENCE and XBRYK, marking Samsung Bioepis’ 10th and 11th EC approvals as well as the company’s first EC approval for an endocrinology biosimilar, add to the company’s growing portfolio in new therapeutic areas.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.
1 International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021. Accessed January 2025.
2 So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633.
3 Lee HA, Kim S, Seo H, Kim S. A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects. Expert Opin Investig Drugs. 2023 Jul-Dec;32(10):959-966. doi: 10.1080/13543784.2023.2273510. Epub 2023 Nov 6. PMID: 37870163.
4 Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowińska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2024 Sep 7:dgae611. doi: 10.1210/clinem/dgae611. Epub ahead of print. PMID: 39243386.
5 Richard Eastell, Bente Langdahl, Yoon-Sok Chung, Rafal Plebanski, Edward Czerwinski, Eva Dokoupilova, Jerzy Supronik, Jan Rosa, Andrzej Mydlak, Anna Rowinska-Osuch, Ki-Hyun Baek, Audrone Urboniene, Robert Mordaka, Sohui Ahn, Young Hee Rho, Jisuk Ban. A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results. Oral presentation at 2024 European Calcified Tissue Society (ECTS) Congress. May 25-28, 2024. Marseille, France.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250215715912/en/
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
Hitachi Announces Strategic Partnership With Anthropic to Strengthen "Lumada 3.0" Through Frontier AI19.5.2026 02:00:00 CEST | Press release
Combining Hitachi’s 110+ years of domain expertise with frontier AI will advance safe real-world deployment of physical AI and strengthen customer AI transformation Deploying advanced AI across all business processes for approximately 290,000 employees to enhance productivity at scale Developing 100,000 AI professional talent and co-creating new HMAX solutions leveraging proven outcomes from Hitachi’s “Customer Zero” approach Establishing the “Frontier AI Deployment Center,” a global organization spanning North America, Europe, and Asia with an initial team of 100 experts Hitachi, Ltd. (TSE:6501, "Hitachi") today announced a strategic partnership with Anthropic PBC (“Anthropic”), a global leader in AI safety research and trusted AI models, to further strengthen the “Lumada 3.0” business model. As artificial intelligence evolves beyond cyberspace to directly influence real-world systems—otherwise known as physical AI—demand is rapidly growing for the safe and seamless deployment of AI i
Moore Nanotechnology Systems (Nanotech) Will Be Acquired by Shibaura Machine Group to Form a New Ultra-Precision Machine Tool Organization18.5.2026 21:36:00 CEST | Press release
MOORE NANOTECHNOLOGY SYSTEMS (“Nanotech”), today announced that it is being acquired by an affiliate of SHIBAURA MACHINE CO., LTD., an industrial machine-tool manufacturer headquartered in Japan. Founded nearly 30 years ago by Len Chaloux and Newman Marsilius III as a standalone subsidiary of the Moore Tool Company, Inc., Nanotech has become a global leader in the design, development and manufacture of state-of-the-art ultra-precision machine tools and associated processes for the production of advanced optical and reflective components. “As the world’s markets continue to develop, finding the right strategic partnerships is essential,” said Mark Boomgarden, President and CEO of Nanotech. “Partnering with Shibaura allows us to combine the true competencies of both organizations under one management team - affording both companies the ability to scale resources and invest on a global stage like never before.” Co-owner Newman Marsilius IV shared, “Moore Nanotechnology Systems grew to a p
First Guests Arrive at Four Seasons Resort and Residences Red Sea at Shura Island from 20 May, as Red Sea Global Launches First JV Resort18.5.2026 20:06:00 CEST | Press release
RSG and Kingdom Holding Company bring first joint venture-developed resort at The Red Sea to market Red Sea Global (RSG), the regenerative tourism developer, has reached a major milestone as Four Seasons Resort and Residences Red Sea at Shura Island welcomes first guests from 20 May, marking the first joint venture-developed resort within its portfolio to enter the market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518349628/en/ An aerial view of Four Seasons Resort and Residences at Shura Island, set along the shoreline with clear views of the Red Sea. Developed in partnership with Kingdom Holding Company (KHC), the launch represents a shared milestone for both organizations and marks a new phase in RSG’s development model, highlighting the growing role of institutional and private sector partnerships in scaling Saudi Arabia’s luxury tourism sector. “With Four Seasons preparing to welcome guests, we are significantly
Belkin Advances Towards Carbon Neutrality in Scope 3 Emissions18.5.2026 18:10:00 CEST | Press release
The company’s 2025 Impact Report highlights its continued progress in emissions reduction, circular design, and responsible packaging Belkin, a leading consumer electronics brand for 40 years, published its 2025 Impact Report, highlighting key achievements and reaffirming its commitment to corporate responsibility. Having achieved carbon neutrality in scope 1 and scope 2 emissions in 2025, the company continues to advance toward scope 3 carbon neutrality through enhanced life cycle assessment capabilities and improved supplier and logistics data collection. In 2025, Belkin calculated 131 product carbon footprints across its portfolio, surpassed 21.6 million PCR products sold, and has achieved a 95% reduction in single-use plastic packaging since 2019, reflecting continued progress in carbon reduction and responsible product design. “As we continue to make progress against our sustainability goals, we are taking deliberate steps to reduce our impact,” said Steven Malony, CEO of Belkin.
Infobip Named a Leader in the 2026 Gartner® Magic Quadrant™ for Communications Platform as a Service18.5.2026 16:25:00 CEST | Press release
Recognized for Completeness of Vision and Ability to Execute Infobip is excited to share that global AI-first cloud communications platform Infobip has been recognized as a Leader in the 2026 Gartner Magic Quadrant for Communications Platform as a Service. Check back for a complimentary copy of the full report soon! In Infobip’s view, this recognition reflects what the company has spent 20 years building: a communications platform that stays focused on what customers actually need and evolves as markets change. Infobip believes that recognition in a fast-moving market comes not from chasing trends, but from disciplined execution and a clear long-term vision. As Infobip marks its 20th year of operations, the company thinks the shift to agentic AI represents the most significant transformation in customer communications in our history. Infobip believes enterprises need a partner that empowers them to move from campaigns and rigid workflows to autonomous, goal-driven interactions, while r
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