On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA.
Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone. First marketed by Amgen as PROLIA® and XGEVA®, denosumab is used to treat conditions associated with bone loss, such as osteoporosis, and to treat bone cancers and prevent fractures in patients with bone metastases.
As we previously reported, Amgen and Accord BioPharma settled their denosumab BPCIA case in July 2025.