Celltrion USA, affiliated to South Korean biopharmaceutical firm Celltrion, Inc., announced the commercial availability of biosimilars STOBOCLO (denosumab-bmwo) and OSENVELT (denosumab-bmwo) in the United States.
STOBOCLO, a receptor activator of NF-?b ligand (RANKL) inhibitor referencing PROLIA (denosumab), is available in 60 mg/mL injection.
OSENVELT, a receptor activator of NF-?b ligand (RANKL) inhibitor referencing XGEVA (denosumab), is available in 120 mg/1.7 mL (70 mg/mL) injection.
Both injections are approved by the FDA based on comprehensive data and clinical evidence confirming the respective therapeutic equivalence.
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, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
The approval also includes 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.
Further, OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also approved 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.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said, "We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars. We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems."
In South Korea, Celltrion shares were losing around 2 percent on Tuesday, to trade at 175,200.00 Korean Won.
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