Posted by Michael Wonder on 27 Dec 2025
Amneal announces FDA approval of denosumab biosimilars referencing Prolia and Xgeva
22 December 2025 - Company expects to commercialize six biosimilars across eight presentations by 2027.
Amneal Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma today announced that the US FDA has approved its biologics licensing applications for Boncresa (denosumab-mobz), a biosimilar referencing Prolia, and Oziltus (denosumab-mobz), a biosimilar referencing Xgeva.
