Fresenius Kabi announces that its Biologic License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) has been approved by the US FDA. These denosumab biosimilars are approved for all indications of the reference products: Prolia (denosumab) and Xgeva (denosumab). Conexxence is approved 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. Bomyntra is approved for use to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. Conexxence has a black box warning and includes a Risk Evaluation and Mitigation Strategy (REMS) program.