FDA Approves Stoboclo and Osenvelt: New Denosumab Biosimilars Set to Revolutionize Osteoporosis and Cancer Treatment

The FDA has approved two new denosumab biosimilars: Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo), set to be available by June 2025. Stoboclo is approved for treating postmenopausal osteoporosis, osteoporosis in men, and bone loss in men undergoing cancer treatment. It also helps women on aromatase inhibitors for breast cancer. Osenvelt is approved for preventing skeletal-related events in multiple myeloma patients and those with bone metastases. It also treats giant cell tumor of bone and hypercalcemia of malignancy.

Approval was based on a phase 3 trial showing similar efficacy to Prolia® (denosumab) in postmenopausal women. Results confirmed comparable bone density improvements and safety. Celltrion USA’s Thomas Nusbickel highlighted the biosimilars’ role in offering cost-effective, high-quality treatments.

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• FDA Approves Celltrion’s Stoboclo and Osenvelt Biosimilars for Osteoporosis and Cancer Treatments

FDA Approves Stoboclo and Osenvelt: New Denosumab Biosimilars Set to Revolutionize Osteoporosis and Cancer Treatment

The FDA has approved two denosumab biosimilars, Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo), both expected to be available by June 2025.

Stoboclo is approved for treating postmenopausal women with osteoporosis at high fracture risk, increasing bone mass in men with osteoporosis and those on glucocorticoid therapy, and boosting bone mass in men undergoing androgen deprivation therapy for prostate cancer and women receiving aromatase inhibitors for breast cancer.

Osenvelt is approved for preventing skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, as well as treating adults and adolescents with unresectable giant cell tumor of bone or tumors likely to result in severe morbidity from surgery, and for treating hypercalcemia of malignancy not responding to bisphosphonate therapy.

The approval was based on a comprehensive clinical trial comparing denosumab-bmwo with the reference product (Prolia) in postmenopausal women with osteoporosis. Results at week 52 showed equivalent efficacy between the biosimilar and Prolia in increasing lumbar spine bone mineral density, with similar outcomes at week 78 after switching treatments. Safety, pharmacokinetics, and immunogenicity data also confirmed the biosimilars’ comparability.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, stated that the approval of Stoboclo and Osenvelt marks progress in providing cost-effective treatments for osteoporosis and cancer-related skeletal issues.

FDA Approves Celltrion’s Stoboclo and Osenvelt Biosimilars for Osteoporosis and Cancer Treatments

Celltrion has received FDA approval for its biosimilars, Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), which are based on Amgen’s Prolia and Xgeva, respectively. Stoboclo is approved for use in postmenopausal women with osteoporosis at high fracture risk, men with osteoporosis, and patients with glucocorticoid-induced osteoporosis. Osenvelt is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treating adolescents with unresectable giant cell tumor of bone, and managing hypercalcemia of malignancy not responsive to bisphosphonate therapy.

The approval is based on Phase III clinical data showing that Stoboclo and Osenvelt are as effective, safe, and well-tolerated as the reference products. Common side effects for Stoboclo included back pain and musculoskeletal issues, while Osenvelt’s most frequent side effects included nausea, asthenia, and hypophosphatemia. These biosimilars offer a cost-effective alternative to Prolia and Xgeva, expanding patient access to crucial therapies. Both treatments are expected to launch in the U.S. by June, following a settlement with Amgen.

According to the International Osteoporosis Foundation, osteoporosis affects a significant portion of the population, particularly postmenopausal women, with one in three women and one in five men over 50 at risk. With an estimated 54 million people in the U.S. at risk, these biosimilars aim to address the growing demand for affordable bone health treatments, improving accessibility to essential therapies. The approval of Stoboclo and Osenvelt is expected to help fill the gap, offering cost-effective alternatives that could benefit millions of individuals who rely on long-term treatments to manage osteoporosis and prevent bone fractures.