**The US Food and Drug Administration (FDA) has approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy denosumab.**
The regulator has approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo) for all indications covered by Amgen’s Prolia and Xgeva, respectively.
Stoboclo has been authorised 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 drug has also been approved 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.
Meanwhile, 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, as well as to treat hypercalcaemia of malignancy refractory to bisphosphonate therapy.
A biosimilar, according to the FDA, is a biological medicine that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
Among the clinical evidence supporting the FDA’s decision on Stoboclo and Osenvelt, which are expected to be available in the US in June 2025, were results from phase 3 trials in postmenopausal women with osteoporosis.
In the studies, Celltrion’s biosimilars demonstrated equivalent efficacy and pharmacodynamics, as well as similar pharmacokinetics and comparable safety and immunogenicity profiles to reference denosumab.
Thomas Nusbickel, chief commercial officer at Celltrion USA, said: “The approval of Stoboclo and Osenvelt is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events.
“Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives.”