FDA to Review Fresenius' Denosumab Biosimilar Application

Fresenius, through its subsidiary Fresenius Kabi, has announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for a biosimilar version of Prolia® (denosumab) and Xgeva® (denosumab). This acceptance marks a significant milestone in the company's efforts to broaden its biosimilars development and product offerings.

The biosimilar candidate targets the treatment of osteoporosis in both men and women, including cases induced by glucocorticoids. Additionally, it is indicated for managing bone loss associated with prostate and breast cancer. This move aligns with Fresenius Kabi's ongoing strategy to enhance patient access to high-quality biological therapies.

Acknowledging the importance of expanding the company's Biopharma platform, this latest BLA submission reinforces Fresenius Kabi's dedication to its growth strategy, termed #FutureFresenius. This initiative emphasizes the company's focus on the development of biosimilar products and other high-value biological treatments.

It should be noted that Prolia® and Xgeva® are established trademarks owned by Amgen Inc. The acceptance of the BLA by the FDA is a critical step in the regulatory process, potentially leading to increased treatment options for patients suffering from osteoporosis and cancer-related bone loss.

Fresenius Kabi's efforts in developing this biosimilar underscore their commitment to providing cost-effective, high-quality biological products that can enhance patient care. This FDA acceptance could pave the way for more affordable and accessible treatment options, continuing the company’s legacy of innovation in the biopharmaceutical sector.