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# Fresenius Prolia, Xgeva Biosimilars Approved
- URL: https://www.fdaweb.com/fresenius-prolia-xgeva-biosimilars-approved/
- Published: 2025-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:56:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158909

FDA has approved the Fresenius Kabi BLAs for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) for all indications of the reference products, Amgen’s Prolia (denosumab) and Xgeva (denosumab) respectively. The company [says](https://www.fresenius-kabi.com/us/news-and-events/fda-approval-denosumab-and-secures-global-settlement-agreement?ref=fdaweb.com) it has reached a global settlement with Amgen for its denosumab biosimilars to permit a mid-year launch in the U.S.

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 to prevent skeletal-related events in adults with multiple myeloma and bone metastases from solid tumors. It also is used to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy and giant cell tumors of bone in adults and skeletally mature adolescents.