Posted by Michael Wonder on 04 Mar 2025
Amneal’s BLA submissions for two denosumab biosimilars accepted for review by US FDA
3 March 2025 - Denosumab biosimilar candidates reference Prolia and Xgeva.
Amneal Pharmaceuticals and mAbxience today announced that the US FDA has accepted for review its biologics license application for two proposed denosumab biosimilars referencing Prolia and Xgeva.
