Ospomyv (denosumab-dssb) / Samsung, Hanmi - LARVOL DELTA

Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE and XBRYK, in Europe (Businesswire) - "OBODENCE (60 mg pre-filled syringe) and XBRYK (120 mg vial) become available across Europe as of December 2025 and January 2026, respectively."

Biosimilar launch • Osteoporosis

Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab. (PubMed, Front Pharmacol) - "Covariate analysis and simulation results revealed no significant differences in PK/PD parameters between SB16 and DEN. The similarity in the PK profile and change in lumbar spine BMD between SB16 and DEN were demonstrated, supporting the potential for SB16 to be substituted for the reference product in the treatment of osteoporosis."

Journal • PK/PD data • Osteoporosis • Rheumatology

Demonstrating Similarity of Denosumab Biosimilar SB16 to Reference Denosumab Using Population PK-PD Modeling (ASBMR 2025) - P1, P3 | No abstract available

Clinical • PK/PD data

Samsung Bioepis, Hanmi offer 13% cost savings with new Prolia biosimilar (Korea Biomedical Review) - "Samsung Bioepis and Hanmi Pharmaceutical on Tuesday jointly launched Obodense (ingredient: denosumab), a biosimilar referencing Amgen’s blockbuster osteoporosis drug Prolia, in Korea....The biosimilar is indicated for the treatment of osteoporosis in postmenopausal women and has been listed for reimbursement at 108,290 won ($80) per 60mg/1mL dose -- approximately 13 percent lower than the original drug."

Biosimilar launch • Osteoporosis

Samsung Bioepis secures approval for Xbryk biosimilar in Korea (Chosun Biz) - "Samsung Bioepis announced on the 30th that it has received marketing authorization for the osteoporosis treatment 'Xgeva (active ingredient denosumab)' biosimilar 'Xbryk' from the Ministry of Food and Drug Safety. Xgeva is an osteoporosis treatment developed by Amgen in the United States, used alongside the endocrine therapy 'Prolia' for postmenopausal osteoporosis and for preventing skeletal complications in patients with bone metastasis as well as in treating giant cell tumors."

Korea approval • Giant Cell Tumor of Bone • Metabolic Disorders • Osteoporosis

Samsung Bioepis wins MRDS approval for osteoporosis biosimilar (Pulse by Maeil Business News Korea) - "Samsung Co. has won marketing approval from the Ministry of Food and Drug Safety for its osteoporosis biosimilar, Obodence. According to the company on Sunday, Obodence is a biosimilar of Prolia, a blockbuster osteoporosis drug developed by U.S.-based Amgen Inc. The reference medicine has been used to treat bone loss in patients with osteoporosis as well as in those undergoing treatment for prostate and breast cancer."

Korea approval • Metabolic Disorders • Osteoporosis

Samsung Bioepis partners with Hanmi for Prolia biosimilar as Celltrion cuts price (Korea Biomedical Review) - "Hanmi Pharmaceutical and Samsung Bioepis are diving into the race for affordable osteoporosis treatments, sealing a joint sales agreement for Bioepsis’ Prolia biosimilar SB16 (denosumab)."

Commercial • Osteoporosis

Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE, XBRYK) (Businesswire) - "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....The EC approval was based on totality of evidence including analytical, non-clinical data, and clinical data."

EMA approval • Metabolic Disorders • Osteoporosis

FDA Approves Samsung Bioepis’ OSPOMYV…(denosumab-dssb), a Biosimilar to Prolia… (Businesswire) - "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....The FDA approval was based on totality of evidence including analytical, non-clinical data, and clinical data....In addition, the FDA granted a provisional determination for...Ospomyv's....interchangeability designation."

FDA approval • Osteoporosis

FDA Approves Samsung Bioepis’…XBRYK (denosumab-dssb), a Biosimilar to…Xgeva (Businesswire) - "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 was based on totality of evidence including analytical, non-clinical data, and clinical data....In addition, the FDA granted a provisional determination for...Xbryk's interchangeability designation."

FDA approval • Metabolic Disorders

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial. (PubMed, Bone) - "Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN."

Clinical • Journal • P3 data • Osteoporosis • Rheumatology

Samsung Bioepis Receives Positive CHMP Opinion for Denosumab Biosimilars, OBODENCE and XBRYK (GlobeNewswire) - "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."

CHMP • Metabolic Disorders • Osteoporosis

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. (PubMed, J Clin Endocrinol Metab) - P3 | "The reported efficacy, PK, PD, safety, and immunogenicity data support the biosimilarity of SB16 to DEN."

Clinical • Journal • P3 data • Orthopedics • Osteoporosis • Rheumatology

A RANDOMIZED, DOUBLE-BLIND, PHASE III STUDY TO COMPARE SB16 (PROPOSED DENOSUMAB BIOSIMILAR) TO REFERENCE DENOSUMAB IN PATIENTS WITH POSTMENOPAUSAL OSTEOPOROSIS: 18-MONTH RESULTS (EULAR 2024) - "The efficacy, PK, PD, safety, and immunogenicity among the treatment groups (SB16+SB16, DEN+DEN, and DEN+SB16) were comparable up to Month 18."

Clinical • P3 data • Osteoporosis • Rheumatology

A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis (ACR Convergence 2023) - P3 | "This study demonstrated biosimilarity of SB16 to DEN through equivalent efficacy and comparable PD, PK, immunogenicity and safety up to Month 12."

Clinical • P3 data • Osteoporosis • Rheumatology

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. (PubMed, Expert Opin Investig Drugs) - P1 | "Thisstudy demonstrated PK bioequivalence between SB16, EU-DEN, and US-DEN inhealthy male subjects. CT.gov identifier:NCT04621318."

Clinical • Journal • PK/PD data

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=457 | Completed | Sponsor: Samsung Bioepis Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=168 | Completed | Sponsor: Samsung Bioepis Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Aug 2021 ➔ Nov 2022 | Trial primary completion date: Aug 2021 ➔ Nov 2022

Trial completion • Trial completion date • Trial primary completion date

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3; N=458; Active, not recruiting; Sponsor: Samsung Bioepis Co., Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Osteoporosis • Rheumatology

"Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab) @Pharmashot @SamsungBioepis https://t.co/RhEEWdIN1u" (@Pharmashot)

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3; N=432; Recruiting; Sponsor: Samsung Bioepis Co., Ltd.

Clinical • New P3 trial • Osteoporosis • Rheumatology