On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates.
The applications for the two candidates, biosimilars to Amgen’s PROLIA (denosumab) and XGEVA (denosumab), respectively, cover “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 tumor of the bone.” According to Fresenius, the marketing authorization applications for its denosumab biosimilar candidates are “based on comprehensive analytical development and analytical similarity assessment supported by two comparative clinical studies (i.e., comparative PK, PD, and immunogenicity study conducted in healthy volunteers and a comparative efficacy, PD, safety, and immunogenicity study conducted in women with PMO).”
Fresenius’s denosumab biosimilars, CONEXXENCE (denosumab-bnht) and BOMYNTRA (denosumab-bnht), referencing PROLIA and XGEVA, respectively, were approved by the FDA on March 25, 2025.
As we previously reported, the EMA also recently issued positive CHMP opinions for Accord’s denosumab biosimilars OSVYRTI and JUBEREQ and Biocon Biologics’ denosumab biosimilars VEVZUO and Denosumab BBL (the brand name is currently under approval).