Celltrion USA 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 and Osenvelt are supported by Celltrion’s comprehensive patient support programs designed to help empower patients to navigate their treatment journeys.

Stoboclo is available in 60 mg/mL injection and is approved:

• To treat postmenopausal women with osteoporosis who are 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
• 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 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
• To treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

“We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “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.”