Fresenius Announces FDA Acceptance for Review of Denosumab Biosimilar Application

Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).

The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.

Prolia® and Xgeva® are registered trademarks of Amgen Inc.