Medscape6d
FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
Healio6d
FDA grants approval to two more denosumab biosimilars
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
Managed Healthcare Executive6d
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi, has ...
Targeted Oncology1d
FDA Oncology Actions: March 2025 Approvals and Designations
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
JD Supra5d
FDA Approves Fresenius’s Denosumab Biosimilars
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
Renal & Urology News29d
Denosumab Biosimilar Stoboclo, Osenvelt Get FDA Approval
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).
Monthly Prescribing Reference29d
Denosumab Biosimilars Stoboclo, Osenvelt Get FDA Approval
During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the biosimilar in the first period ...