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 fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
The products are expected to be available in June 2025. Osenvelt is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid ...
Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming ...
After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...
The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...
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 ...
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).