Number 5: Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in ...
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate ...
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
The Food and Drug Administration (FDA) has approved Stoboclo ® (denosumab-bmwo), a biosimilar to Prolia ® (denosumab), and Osenvelt ® (denosumab-bmwo), a biosimilar to Xgeva ® (denosumab).
After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...
Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing ...
On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; 70 mg/mL injection), referencing Amgen’s ...
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