Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...

Amneal wins FDA approval for two denosumab biosimilars, expanding lower-cost treatment options for bone loss and cancer patients.

Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...

"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 ...

Stoboclo and Osenvelt, biosimilars of Prolia and Xgeva, are approved for various cancer-related bone conditions, offering cost-effective alternatives. FDA approval confirms therapeutic equivalence of ...