On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Fresenius the fourth company to receive FDA approval for a pair of denosumab biosimilars, joining Celltrion, Samsung, and Sandoz.
Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss. The FDA approved CONEXXENCE ® for use in various adult patient populations at high risk for fractures, including those with osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. The FDA approved BOMYNTRA ® to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy and giant cell tumor of bone in adults and skeletally mature adolescents, and to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors.
On the same day, Fresenius also announced that they have “reached a global settlement with Amgen for [their] denosumab biosimilar candidates.” This announcement follows our previous report that Amgen and Fresenius settled their BPCIA case on March 7, 2025.