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

OBODENCE™ and XBRYK™ recommended for approval by the European Medicines Agency for all indications referencing Prolia and Xgeva, respectivelyINCHEON, South Korea, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two denosumab biosimilars – OBODENCE™ (60 mg pre-filled syringe) referencing Prolia (denosumab) and XBRYK™ (120mg vial) referencing Xgeva (denosumab) – also known as SB16. OBODENCE has been recommended for approval 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 has been recommended for approval 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. “In Europe alone, approximately 22.1% of women and 6.6% of men are affected by osteoporosis. Osteoporosis and cancer-related bone loss can lead to skeletal fractures, seriously affecting the quality of life of patients. Enhancing access to treatment options is essential for improving both patient outcomes and quality of life (QoL) as it allows timely treatment for patients,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “If approved, OBODENCE/XBRYK would become our first endocrinology biosimilar, adding to our growing portfolio of biosimilar products that are helping to improve patient’s quality of life and access to treatments, and relieve the financial burden of healthcare systems.” The CHMP’s positive opinion was based on a 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.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 The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant marketing authorizations for OBODENCE and XBRYK. If a marketing authorization is granted by the EC, OBODENCE and XBRYK would become Samsung Bioepis’ first endocrinology biosimilar approved in Europe, further expanding the company’s biosimilars portfolio. About SB16 Phase 1 Study4 The study is a randomized, double-blind, three-arm, parallel group, single-dose study conducted in 168 healthy male participants. Participants were randomized in a ratio of 1:1:1 to receive a single 60 mg dose of either SB16, EU-DEN, or US-DEN subcutaneously. PK, PD, safety, tolerability, and immunogenicity were evaluated for 197 days. The primary PK endpoints were AUC from time zero to infinity, and maximum serum concentration. Equivalence was determined if 90% CIs for the ratio of geometric LSMeans of the treatment groups compared were within the equivalence margin of 0.80 to 1.25. About the SB16 Phase 3 Study5 The study is a randomized, double-blind, multi-center study conducted in 457 PMO patients. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at Month 0, Month 6, and Month 12. At Month 12, patients in DEN group were re-randomized in a 1:1 ratio to switch to SB16 or maintain DEN. The primary endpoint was percent (%) change from baseline in lumbar spine BMD at Month 12. Equivalence between SB16 and DEN was declared if the 95% CI (per-protocol set) and 90% CI (full-analysis set) of LSMeans difference of % change in lumbar spine BMD at Month 12 were within the pre-defined equivalence margin. Other secondary efficacy, PD (serum C-telopeptide of type I collagen [CTX] and procollagen type I N-terminal propeptide [P1NP]), PK, immunogenicity, and safety endpoints were also measured. 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. MEDIA CONTACT Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com ___________________________ 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. 4 Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects. Available at: https://www.clinicaltrials.gov/study/NCT04621318 (Accessed November 2024) 5 A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis. Available at: https://www.clinicaltrials.gov/study/NCT04664959 (Accessed November 2024)