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FDA Approves Biosimilar Denosumab-dssb to Treat Osteoporosis-, Cancer-Related Bone Loss
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Key Takeaways
- The FDA approved Xbryk and Ospomyv, biosimilars referencing denosumab, for osteoporosis and cancer-related bone loss treatment.
- These approvals aim to improve patient access and reduce treatment costs in the US.
The approval in multiple indications is designed to improve access to effective, proven treatments for skeletal fractures, which can greatly reduce patient quality of life.
The FDA has approved the biologics license applications (BLAs) for Xbryk (denosumab-dssb 120 mg vial; Samsung Bioepis Co) and Ospomyv (denosumab-dssb 60 mg prefilled syringe; Samsung Bioepis Co), both biosimilars referencing denosumab (Prolia, Xgeva; Amgen) for the treatment of osteoporosis- and cancer-related bone loss, respectively.1
Denosumab (Prolia [pictured], Xbryk) is approved as a pre-filled syringe and a vial for patients with osteoporosis- and cancer-related bone loss. | Image Credit: © Nicola.K.photos - stock.adobe.com
“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,” Byoungin Jung, vice president at Samsung Bioepis, said in the news release. “By providing quality-proven biosimilars, we are helping to address a critical health care need and reduce the burden of skeletal fractures that impact patients’ quality of life.”1
Prolia has been approved to treat bone loss in multiple patient populations with osteoporosis. These include for use in 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 non-metastatic prostate cancer, and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.1
Xgeva, also previously approved by the FDA, is indicated 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 that is refractory to bisphosphonate therapy. The approval of biosimilars Xbryk and Ospomyv offers critical new treatment options for patients with a high burden on their quality of life due to bone loss.1
A totality of evidence, including analytical, non-clinical, and clinical data, provided backing for the FDA approvals. Firstly, results from a randomized, double-blind, 3-arm, parallel group, single-dose phase 1 clinical trial indicated the pharmacokinetic (PK) equivalence between SB-16 and denosumab sourced from both the US and Europe in healthy male patients. Additionally, a randomized double-blind, multi-center phase 3 trial (NCT04664959) showed equivalent efficacy and comparable safety profiles between SB16 and reference denosumab in patients with postmenopausal osteoporosis.1,2
Patients in the phase 3 trial were administered SB16 subcutaneously at month 0, month 6, and month 12. Upon randomization, 225 individuals were assigned to each treatment. Investigators found that the mean percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months was 5.6% and 5.3% for SB16 and the denosumab reference product, respectively. Similar rates were also found for hip BMD (3.5% and 3.2%, respectively) and femoral neck BMD (2.8% and 2.3%, respectively).2
Follow-up data from that trial indicated that switching a patient to SB16 from the reference denosumab led to comparable efficacy and safety for up to 18 months, with lumbar spine BMD being approximately 6.77% for each product, according to investigators. Mean change from baseline for both hip BMD and femoral neck BMD were also comparable at 18 months.2
REFERENCES
1. Samsung Bioepis Co. FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva. BusinessWire. News Release. Released February 15, 2025. Accessed February 17, 2025. https://www.businesswire.com/news/home/20250215814020/en/FDA-Approves-Samsung-Bioepis%E2%80%99-OSPOMYV%E2%84%A2-XBRYK%E2%84%A2-denosumab-dssb-a-Biosimilar-to-Prolia-and-Xgeva
2. Gallagher A. Study finds similarities between SB16 and denosumab for osteoporosis treatment up to 18 months. Pharmacy Times. Published June 14, 2024. Accessed February 17, 2025. https://www.pharmacytimes.com/view/study-finds-similarities-between-sb16-and-denosumab-for-osteoporosis-treatment-up-to-18-months
