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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
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
Mapi, climate protection is a central aspect of the Fresenius Groups sustainability ambition – why so?
Mapi Henríquez de Armas: Climate change is no longer an abstract issue. Its effects, such as heatwaves and floods, frequently dominate global headlines and are becoming increasingly evident. Our company is not immune to these changes. On the one hand, we need to adapt our business activities to the shifting conditions - for example, in our healthcare facilities, we have to prepare for rising temperatures and more severe weather events to be able to provide best possible care for our patients also in the future. On the other hand, we also contribute to greenhouse gas emissions. Hence, we have a responsibility to contribute to climate protection and play a role in limiting global warming, the driving force behind climate change. While adapting to climate change is managed at a local level, we have set global emission reduction targets that help us to meet related expectations and to coordinate our efforts.
What do we want to achieve?
Mapi Henríquez de Armas: By 2030, we will reduce the greenhouse gases from our business activities and energy consumption by 50% compared to 2020. Our goal is to be climate-neutral in our own operations by 2040, through increasing energy efficiency and utilizing renewable energy sources. Any remaining emissions will be offset, for example, by supporting climate protection projects. At Quirónsalud, we have defined several impactful measures as part of our Energy and Climate Change Adaptation and Mitigation Plan. For example, the Sustainable Anesthesia Project aims to eliminate the use of nitrous oxide and desflurane in anesthetic practices, with recommendation for low flow and alternative options like intravenous therapy, without compromising patient care. Additionally, we are digitalizing processes and unifying building management systems across hospitals, allowing for coordinated and automated management of electricity, gas, and water consumption to ensure optimal performance and further enhance resource efficiency.
We are also focusing on upgrading infrastructure by replacing heating and cooling systems in our facilities with more efficient, lower-carbon alternatives, such as switching from diesel to natural gas boilers.
Our long-term goal is to achieve net zero by 2050, meaning that both our upstream and downstream value chain activities will also be climate neutral.
How realistic is it that we will achieve our Group goals and what drives you in your related work?
Mapi Henríquez de Armas: Overall, we are on the right track. Last year, for example, we reduced our our direct greenhouse gas emissions (Scope 1 and 2 emissions) as a Group by 27,2% compared to the base year 2020. The levers available to achieve our targets are the same everywhere. Wherever possible, we aim to increase energy efficiency and use renewable energy. Since 2022, Quirónsalud has been incorporating solar panels for electricity generation in our hospitals as part of our efforts to reduce our climate impact and ensure the sustainability of our energy supply. This has resulted in generating 5.6 GWh of electricity, amounting to 6% of the total electricity consumed in these centers.
Given that the healthcare sector accounts for around 4-5% of global greenhouse gas emissions, I am convinced that, as a leading company in the sector, we have a responsibility when it comes to climate protection. For me, the climate targets and a clear path towards decarbonization are proof that the issue is being taken seriously—both at the management and operational levels. It motivates me to know, that we as a company are fully committed to reducing our carbon footprint and fighting climate change and its consequences while continuing to deliver the best healthcare results and experiences for our patients.
The Fresenius healthcare group is continuously expanding its range of innovative products. A new laboratory and office building with a technical center called KabiLab D20 is being built at Daimlerstrasse 20 on the Fresenius campus in Bad Homburg. It will feature laboratories, a total of 90 desk-sharing workstations, meeting rooms, and storage rooms on an area totaling around 5,000 m2. The move to the new building is planned for mid-2026.
Once completed, around 70 employees from the Fresenius Kabi Business Unit Nutrition currently working in Bad Homburg and Friedberg will relocate to the new building. Among others, they are working on further development of the Fresubin enteral nutrition product portfolio as well as on a special device for producing patient-specific parenteral nutrition. Patients who are unable to meet their nutritional needs through their normal diet need enteral nutrition such as Fresubin. Parenteral nutrition is a form of artificial nutrition that is administered intravenously rather than via the gastrointestinal tract. Fresenius is the world’s leading provider in this field. With the rise in metabolic disorders and chronic diseases such as diabetes, the global demand for special clinical nutrition is expected to increase significantly in the coming years.
The KabiLab is being built with sustainability in mind: Parts of the existing building structure and technical infrastructure are being used, which will significantly reduce CO2 emissions compared to a new building. In future, photovoltaic systems will supply green electricity, an efficient heat pump will be used to heat the rooms, and rainwater will be stored to water the new green spaces.
Fresenius currently employs around 2,100 people in Bad Homburg and a further 300 in neighboring Oberursel, who will also move to the campus in Bad Homburg by the middle of the year.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
