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
NTT DATA Signs Strategic Collaboration Agreement with AWS to Accelerate Enterprise Cloud and Agentic AI Adoption29.1.2026 14:00:00 CET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announced a multi-year Strategic Collaboration Agreement (SCA) with Amazon Web Services (AWS) to help enterprises modernize legacy systems, adopt agentic AI responsibly and scale innovation across industries. Combining NTT DATA’s expertise in cloud transformation, cloud-native modernization and Agentic AI with the scale and innovation velocity of AWS services, the collaboration will deliver tailored enterprise solutions that modernize mission-critical workloads, build secure cloud foundations and drive measurable business outcomes across regulated and high-growth industries. Under the agreement, NTT DATA and AWS will accelerate enterprise transformation in four priority areas: AI-driven large-scale cloud transformation: Accelerating the migration and modernization of on-premises workloads on AWS, leveraging generative and agentic AI, automation and data platforms to unlock new business models and drive int
U.S. Department of Energy and Kyoto Fusioneering Launch Strategic Partnership to Build Critical Fusion Infrastructure and Accelerate Deployment of Commercial Fusion Power29.1.2026 14:00:00 CET | Press release
Today, the U.S. Department of Energy (DOE) and Kyoto Fusioneering (KF) established a landmark partnership to deliver critical fusion infrastructure and perform collaborative R&D to drive down technology and commercialization risk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127164854/en/ Anchored by a new public-private partnership between KF and Oak Ridge National Laboratory (ORNL) that leverages each institution’s expertise in fusion technology to develop world-leading fusion test facilities and technology, this agreement establishes a new paradigm in U.S.-Japan allied cooperation and public-private partnership towards accelerating the deployment of commercial fusion power. Under the new partnership, KF and ORNL will commence joint research and development activities focused on fusion breeding blanket systems, a critical technology for producing the tritium fuel needed to sustain fusion power generation. This include
Esri Earns ISO Certification, Reinforcing Commitment to Data Security29.1.2026 14:00:00 CET | Press release
International Standard Ensures ArcGIS Readiness to Protect Information, Compliance Across Industries Esri, the global leader in location intelligence, has received ISO/IEC 27001:2022 certification. This certification enables Esri's ArcGIS users to meet data residency and local regulatory requirements and ensures that Esri’s security practices comply with the requirements set by the International Organization for Standardization (ISO). ISO/IEC 27001:2022 certification provides a globally recognized framework for establishing, implementing, maintaining, and continually improving an information security management system. Esri's certification demonstrates that its system preserves the confidentiality, integrity, and availability of the platforms, services, and applications used to process, transmit, and store customer assets. "As enterprises simultaneously navigate escalating cyber threats and complex data residency regulations, our certification provides critical assurance that we mainta
Dreamstime Adds Ten More Language Versions, Reaching 23 in Total29.1.2026 13:00:00 CET | Press release
Dreamstime, the world’s largest stock photography community, announced today the addition of new language versions—Czech, Japanese, Korean, Hindi, Turkish, Indonesian, Danish, and Norwegian—to expand its global reach and provide a more comprehensive digital experience worldwide. Hebrew and Arabic will be launched next. Key Takeaways: Dreamstime expands into 23 languages, increasing global reach and accessibility. AI-powered translation improves search relevance, onboarding, and cultural discovery. With billions of new pages and coverage in almost every country worldwide in native, official, or very popular languages, this is Dreamstime’s most prolific launch in its 25-year history. The platform already operates in 13 languages: English, French, Polish, Italian, Spanish, Portuguese, Dutch, Russian, Greek, Chinese, Swedish, German, and Romanian. With a stock photography collection of over 350 million files and millions of new items added monthly, Dreamstime manages a constantly growing d
NIQ Launches Breakthrough Framework That Exposes Billions Lost to the Say–Do Gap29.1.2026 13:00:00 CET | Press release
The new global framework quantifies the disconnect between consumer intent and real‑world buying behavior, unlocking powerful paths to reclaim volume and fuel growth NielsenIQ (NYSE: NIQ) today announced the launch of its Say–Do Gap Measurement Framework, an innovative behavioral metric set to transform how brands and retailers understand modern consumers and navigate a pressing challenge: consumers who say one thing but buy another. With economic uncertainty, shifting priorities, and increasingly value‑driven decision-making changing consumer habits, this growing disconnect has cost the industry more than 13 billion unit sales over the past five years—losses many companies can no longer afford to overlook. By unifying deep attitudinal insights with verified purchase data across 25+ global markets, the Say–Do Framework bridges this gap and exposes where brands are losing momentum, where unmet demand is hiding, and where opportunity is silently compounding. Brands and retailers can now
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