Korea's Celltrion announces US launch of denosumab biosimilars for osteoporosis treatment

July 8, 2025 | Tuesday | News

Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of patients in the US

Celltrion has announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively, are commercially available in the United States.

STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat 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 to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

STOBOCLO and OSENVELT are supported by South Korean firm Celltrion's comprehensive patient support programmes designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT® Patient Support Programme and the Celltrion CARES™ Co-pay Assistance Programme. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. 

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