FDA Grants Approval to Fresenius Kabi’s Denosumab Biosimilars, Expanding Treatment Options The FDA has approved Fresenius Kabi Biopharma’s denosumab biosimilars, Conexxence and Bomyntra, for all indications of Prolia and Xgeva. The decision, part of a global settlement with Amgen, will allow U.S. launches in mid-2025, potentially increasing patient access to affordable osteoporosis and bone metastases therapies.456