Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. 

Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later end of November 2025 subject to regulatory approval.

The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.

*Prolia® and Xgeva®* are registered trademarks of Amgen Inc.
**Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. 

Read the full press release here.

Please click to see full  Prescribing Information for Conexxence®.
Please click to see full  Prescribing Information  for Bomyntra®.
 

Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. 

Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later end of November 2025 subject to regulatory approval.

The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.

*Prolia® and Xgeva®* are registered trademarks of Amgen Inc.
**Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. 

Read the full press release here.

Please click to see full Prescribing Information for Conexxence®.
Please click to see full Prescribing Information for Bomyntra®.
 

Today, Fresenius published its 2024 Annual Report. As already announced in February, the healthcare group grew profitably in the past year and achieved its outlook, which was raised twice, through consistently good business performance. Group revenue before special items increased to €21.5 billion, with organic growth of 8%. Fresenius was also able to reduce net debt by €2 billion in 2024.

“Our #FutureFresenius program, which we launched at the end of 2022, is having an impact. The “new” Fresenius is much more focused. We are concentrating on Fresenius Kabi and Fresenius Helios. These are growing profitably and under their own steam,” said Michael Sen, Chairman of the Management Board of Fresenius. “Growth, higher margins, more cash, lower debt – all this has created value: From the beginning of October 2022, when we prepared the ReSet, until February 28, 2025, the share price rose by 76%.”

For the first time, the Annual Report includes a sustainability report in accordance with the European Sustainability Reporting Standards (ESRS). This replaces the Non-financial Report of previous Annual Reports and expands and supplements reporting topics and details. In addition, the ESRS report, like the financial report, is audited externally.

The 2024 Annual Report is available in German and English as a PDF file and as an online version.

Further publication and event dates for 2025:

·       04/24/2025: Publication of Sustainability Highlights Magazine

·       05/07/2025: Publication of the financial results for Q1 2025

·       05/23/2025: Annual General Meeting

·       08/06/2025: Publication of the financial results for Q2 2025

·       11/05/2025: Publication of the financial results for Q3 2025