11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s marketing authorisation applications for its biosimilar candidates of Prolia (denosumab) and Xgeva (denosumab).

The two applications include all indications covered by the reference products for treating different conditions including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumour of the bone.

Read Fresenius Kabi press release