Denosumab CHMP Positive Opinion

Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for its denosumab biosimilar candidates for the treatment of osteoporosis and other bone-related conditions.

The biosimilars are recommended for approval for all indications of the reference products ¹Prolia® (denosumab) and ²Xgeva® (denosumab) from AMGEN.

The CHMP positive opinion marks an important step in Fresenius Kabi's efforts to enhance patient access to biosimilar products and expand its capabilities and portfolio in biosimilars development. Developing the company's Biopharma platform is a key element of #FutureFresenius.

¹Prolia® and ²Xgeva® are registered trademarks of Amgen Inc.