Denosumab-dssb

INCHEON, Korea I February 15, 2025 I Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively. In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk’s interchangeability designation. OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. XBRYK, referencing Xgeva, has been approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. “The FDA approval of OSPOMYV and XBRYK marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US. By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas.” The FDA 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, AUC from time zero to the last quantifiable concentration, and maximum serum concentration. 1 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. 2,3 OSPOMYV and XBRYK, marks Samsung Bioepis’ 9 th and 10 th FDA approved medicines as well as the company’s first FDA approval for an endocrinology biosimilar, setting another milestone for the company to broaden its biosimilar portfolio that cover a spectrum of therapeutic areas including immunology, oncology, ophthalmology, hematology and endocrinology. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: SELECTED SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV HERE , which includes the Boxed Warning, Medication Guide and Instructions for Use. XBRYK™ (denosumab-dssb) injection, for subcutaneous use Xbryk is a RANK ligand (RANKL) inhibitor indicated for: SELECTED SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS These highlights do not include all the information needed to use XBRYK safely and effectively. See full prescribing information for XBRYK HERE , which includes the Boxed Warning, Medication Guide and Instructions for Use. 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 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. 2 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. 3 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. SOURCE: Samsung Bioepis

INCHEON, Korea--(BUSINESS WIRE)--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.