FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk
Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in multiple myeloma and solid tumor bone metastases.
Image Credit: Adobe Stock Images/TANABOON
The FDA has approved Samsung Bioepis’ Ospomyv (denosumab-dssb; SB16) and Xbryk (denosumab-dssb; SB16), biosimilars referencing Amgen’s Prolia and Xgeva, respectively. Ospomyv is indicated for osteoporosis treatment in postmenopausal women and men at high risk of fracture, as well as for patients undergoing androgen deprivation or aromatase inhibitor therapy. Additionally, Xbryk is approved for preventing skeletal-related events in patients with multiple myeloma and solid tumor bone metastases, treating unresectable giant-cell tumors of bone, and addressing bisphosphonate-refractory hypercalcemia of malignancy.1
“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, VP, regulatory affairs team leader, Samsung Bioepis, in a press release. “This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas.”
Approval was based on results from Phase I and Phase III clinical trials, including analytical data, non-clinical data, and clinical data. This included a Phase I randomized, double-blind, three-arm, parallel group, single-dose trial, which demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab, and US-sourced denosumab in healthy male participants. Results of the study met all primary PK endpoints, including 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.
Additionally, a Phase IIIrandomized, double-blind, multi-center study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics. The primary endpoint was the percent change from baseline in lumbar spine bone mineral density at one year and a follow up of 18 months.
Samsung Bioepis warns that Ospomyv and Xbryk are contraindicated in patients with known hypersensitivity to denosumab products and hypocalcemia. Ospomyv is also contraindicated in patients who are pregnant. Adverse events (AEs) of Ospomyv include dermatologic reactions, severe joint, bone, and muscle pain, and serious skin infections. AEs of Xbryk include embryo-fetal toxicity, hypercalcemia, osteonecrosis of the jaw, and fractures to the vertebrae and femoral bone.1
According to the International Osteoporosis Foundation, osteoporosis affects one in three women and one in five men over 50 years of age globally. In Europe, the United States, and Japan, it is estimated that a total of 75 million people are currently living with osteoporosis. For the United States, this accounts for around 10.2 million people, with 54 million currently at risk. Additionally, 80% of people with osteoporosis in the United States are women.2
According to the Johns Hopkins Arthritis Center, 30% of Caucasian postmenopausal women in the United States have osteoporosis. Additionally, the prevalence of osteoporosis in Caucasian postmenopausal women is around 14% between 50 and 59 years of age, 22% in women between 60 and 69 years of age, 39% in women between 70 and 79 years of age, and 70% in women over 80 years of age.3 In men, the numbers decrease significantly, with 3.3% of men between 50 and 64 years of age developing osteoporosis and 5.7% in men over 65 years of age.4
According to Samgsung Bioepsis, the approvals mark the company’s first FDA approval for endocrinology biosimilars.1
References
1. FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva. Business Wire. February 15, 2025. Accessed February 18, 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. Epidemiology. IOF. Accessed February 18, 2025. https://www.osteoporosis.foundation/health-professionals/about-osteoporosis/epidemiology
3. Osteoporosis Information. John Hopkins Arthritis Center. Accessed February 18, 2025. https://www.hopkinsarthritis.org/arthritis-info/osteoporosis-info/
4. How common is osteoporosis? Healthline. Accessed February 18, 2025. https://www.healthline.com/health/osteoporosis/prevalence-of-osteoporosis
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