Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
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
New Needle-Free Treatment Option for Life-Threatening Anaphylaxis, EURneffy®, Now Available in the UK20.10.2025 10:01:00 CEST | Press release
For decades, traditional adrenaline auto-injectors (AAIs) have been the only available treatment for anaphylaxis—a life-threatening allergic reaction.1,2 Yet from today, the UK’s first needle-free emergency anaphylaxis treatment, the EURneffy® nasal adrenaline spray, is available on prescription.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251020480135/en/ EURneffy® 2 mg nasal spray offers a simple-to-use,3,4 pocket-sized alternative to traditional AAIs, with the potential to transform the lives of those with severe allergies in the UK. It is designed to be portable and ready-to-use in emergencies,3 offering a new alternative to traditional AAIs, including for those who struggle with needles or need a more convenient option they can rely on. EURneffy® also has a longer shelf life and can withstand temperature changes better than traditional AAIs,3,5 meaning fewer trips to the GP for a new prescription. Simon Williams, Ch
Leading Global Businesses Unite to Launch Carbon Measures20.10.2025 10:00:00 CEST | Press release
New coalition to advance global carbon accounting framework and champion market-based solutions that drive emissions reductionsAmy Brachio, former Ernst & Young global vice chair and head of sustainability, named CEO Carbon Measures, a new global coalition representing major businesses from diverse industries and geographies, launched today to establish a more accurate carbon accounting framework and drive market-based solutions to reduce emissions at the lowest cost. The coalition’s work will leverage sound science and the principles of financial accounting to help enable a ledger-based carbon accounting framework that is substantially more accurate, eliminates double counting and addresses current information gaps. By better tracking emissions through the global economy, this new framework will help businesses differentiate their products and governments make more informed policy decisions. Carbon Measures is calling for new policy that unlocks innovation, competition and the power o
Valeo Foods Group Recognised for Sustainability Leadership with EcoVadis Platinum Medal20.10.2025 09:00:00 CEST | Press release
Valeo Foods Group, one of Europe's leading producers of quality sweets, treats and snacks has been awarded a Platinum Medal, the highest recognition level, in the EcoVadis sustainability assessment. Valeo Foods now ranks among the top one percent of companies evaluated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251020547491/en/ Valeo Foods Group recognised for sustainability leadership with EcoVadis Platinum Medal. Ronald Kers, Valeo Foods Group CEO said “Achieving EcoVadis Platinum rating is a proud moment for our business. It reflects the dedication of our people and our determination to integrate sustainability into everything we do – from how we source and produce, to how we support communities and protect the planet.” Dr Grainne O’Halloran, Head of Sustainability at Valeo Foods added: “We are incredibly proud to have achieved EcoVadis Platinum Medal this year. Our increased score reflects our ongoing commitment to
Lazard Appoints Edouard Panié as Managing Director and Co-Head of European Financial Sponsors Coverage20.10.2025 08:00:00 CEST | Press release
Lazard, Inc. (NYSE: LAZ) today announced the appointment of Edouard Panié as Managing Director and Co-Head of the European Financial Sponsors Coverage. He will report to Klaus H. Hessberger, Global Co-Head and Head of Europe for Lazard’s Financial Sponsors Group, to further strengthen the firm’s presence and partnerships with financial sponsors across the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251019307537/en/ Edouard Panié Mr. Panié joins from Goldman Sachs, where he was a Managing Director for nearly two decades, advising on more than 60 landmark M&A, debt, and equity transactions for leading alternative asset managers in private equity, growth equity, and infrastructure, as well as entrepreneurs, families, and corporates. “Private capital is playing an increasingly pivotal role in shaping industries and driving growth. Edouard’s extensive experience and relationships will strengthen Lazard’s ability to pro
Lone Star Announces Sale of Xella to Holcim20.10.2025 06:40:00 CEST | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund X, LP of a binding agreement to sell Xella Group (“Xella”), a leading provider of walling solutions, to Holcim, the leading partner for sustainable construction. The transaction values Xella at approximately €1.85 billion. Headquartered in Duisburg, Germany, Xella is a European provider of efficient and sustainable walling solutions for the entire house shell, operating brands such as Ytong, Silka, Hebel and Multipor. The company employs more than 4,000 team members. In partnership with Lone Star, Xella has taken significant strides in recent years to optimize its offering by strategically focusing the business on walling solutions, while also enhancing its commercial and digital capabilities. Under Lone Star’s stewardship, Xella has also continued to progress its sustainability initiatives. Today, the business stands as a market leader in its sector with a strong reputation for a people-first c
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