Celltrion USA, a subsidiary of South Korea-based biopharmaceutical company Celltrion, announced on Monday 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 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. It is available in a 60 mg/ml injection.
OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, to treat 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, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. It is available in a 120 mg/1.7 ml (70 mg/ml) injection.
Celltrion says that it offers a suite of resources, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program, services that may allow eligible, uninsured patients to receive STOBOCLO and OSENVELT at no cost.
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