Celltrion USA has officially launched its highly anticipated denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), in the United States, marking a significant step in expanding access to high-quality, more affordable biologic medicines. These biosimilars are now commercially available across the U.S., offering direct alternatives to Amgen's PROLIA® and XGEVA®, respectively, following their comprehensive FDA approval for all the original indications of their reference products.

STOBOCLO® (60 mg/mL injection) is approved for a broad range of bone health conditions, including treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis at high risk for fracture, managing glucocorticoid-induced osteoporosis in both men and women at high risk for fracture, and increasing bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, as well as women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Conversely, OSENVELT® (120 mg/1.7 mL injection) addresses severe bone complications in cancer patients. It is indicated for the prevention of skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors. Additionally, OSENVELT is approved for treating adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection would likely lead to severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

This commercial launch follows a global settlement reached with Amgen, paving the way for Celltrion to introduce these crucial biosimilars to the U.S. market. Celltrion USA's Chief Commercial Officer, Thomas Nusbickel, emphasized that this introduction underscores the company's commitment to providing valuable alternative treatment options for patients and healthcare professionals, building on its strong heritage in biosimilars to contribute to the overall sustainability of healthcare systems. To further support patients, Celltrion is providing comprehensive support programs, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program, which may even offer the medications at no cost for uninsured patients. This launch significantly expands Celltrion's biosimilar portfolio, which already spans immunology, oncology, gastroenterology, allergy, and endocrinology, reinforcing their dedication to delivering accessible, transformative treatment options.