Fresenius announces FDA acceptance for review of denosumab biosimilar application

Fresenius Kabi

27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application for its biosimilar candidate of Prolia (denosumab) and Xgeva (denosumab).

The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

Read Fresenius press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Biosimilar , Dossier