Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

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• Acquisition of the remaining 45% stake in mAbxience establishes a wholly owned, vertically integrated biopharma business covering the full value chain from research through commercialization
• Full ownership enhances control over future investments, manufacturing capacity, and decision-making; strengthening Fresenius' competitive position in the fast-growing biosimilars market of more than €180 billion by 2035
• Transaction supports the #FutureFresenius strategy by increasing exposure to a scalable, high-growth biopharma platform, and enabling full participation in future value creation
• The acquisition is expected to be immediately accretive to Group core earnings per share from completion

Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) today announced that it has acquired the remaining 45% of mAbxience Holding S.L. (mAbxience) from Insud Pharma S.L. and Invim Corporativo, S.L. for a total consideration of up to €750 million including a contingent payment of €50 million upon site-approvals. The transaction was signed and completed on 30 September 2026 with no regulatory approvals required.

Fresenius acquired a 55% majority stake in mAbxience in August 2022 and has controlled and consolidated the business since then. Full ownership completes that structure: the biosimilars platform is now wholly owned within Fresenius Kabi’s Biopharma business, which covers the full value chain from research through to commercialization.

The acquisition builds on a successful partnership that has already delivered important development, manufacturing, technology-transfer, and regulatory milestones. Taking full ownership gives Fresenius the entire economic benefit of the platform and greater strategic flexibility to invest in manufacturing capacity, select future biosimilar opportunities, and pursue licensing partnerships at a time when a large wave of biologics is losing exclusivity. This fast-growing market is expected to grow approximately six times by 2035 to more than €180 billion. Bringing the organizations together under full ownership creates a stronger platform to enhance quality, supply resilience, and operational freedom, while supporting future innovation, and broader patient access to high-quality biosimilars. The transaction is consistent with the capital allocation priorities set out under #FutureFresenius.

Michael Sen, Chief Executive Officer of Fresenius, said: “Completing the acquisition of mAbxience marks the next milestone in building a leading, vertically integrated biopharma business at scale. When we first invested in mAbxience four years ago, the market opportunity was promising but still evolving. Our initial majority stake gave us access to a highly competitive platform while managing risk. Since then, the market has developed strongly, mAbxience has delivered, and Fresenius now has the financial strength to take this next step. Full ownership gives us complete control over cost, capacity and launch timing, and full economic benefit, as the next wave of biologics loses exclusivity. For patients, that means dependable access to high-quality biosimilars; for shareholders, it is a disciplined investment in a business we know well.”

Jurgen Van Broeck, Chief Executive Officer of mAbxience, said: “mAbxience was founded to serve patients, while proving that world-class biologics could be developed and manufactured at a cost the world could afford. Since 2022, our partnership with Fresenius has demonstrated the strength of combining our people, expertise, and capabilities. I would also like to recognize and thank Insud Pharma for its support and commitment over the past decade. The success of mAbxience today is built on the vision, dedication and hard work of many people who have contributed to this journey from the very beginning. Full ownership is the natural next step and creates an even stronger platform for innovation, growth, and long-term impact for patients, customers, and partners. As we begin this next chapter together, we will continue to build on the entrepreneurial spirit, scientific expertise, and commitment to patients that have driven mAbxience’s success.”

mAbxience is a leading global biopharmaceutical company that operates three multi-product state-of-the-art drug substance facilities in Spain and Latin America and employs over 1,300 people. mAbxience develops and manufactures biosimilar monoclonal antibodies and provides contract development and manufacturing services to partners. In 2025 mAbxience generated more than €320 million in revenue and contributed earnings before interest, taxes, depreciation, and amortization (EBITDA) margin that was accretive to the overall Fresenius Kabi margin. Its portfolio comprises four products on the market and eight candidates in development. Together with Fresenius Kabi’s development, regulatory, and commercial capabilities it covers the full value chain from laboratory to patient.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business, reporting to Dr. Sang-Jin Pak, President Biopharma at Fresenius.

Full ownership positions the platform for further scale, including pipeline expansion opportunities, within Fresenius’ unchanged financial framework. 

Financial Considerations

• Consideration: Up to €750 million in cash, including a contingent payment of €50 million upon site-approvals.
• Funding: Available liquidity and operating cash flow. No new financing was required.
• Balance sheet: The consideration settles the put option liability over the 45% non-controlling interest recognized in the Group’s consolidated balance sheet. Following the transaction, net debt to EBITDA is expected to increase by approximately 20 basis points, while leverage for the full year is expected to be towards the lower end of the self-imposed target corridor of 2.5x to 3.0x.
• Accounting: Under International Financial Reporting Standards, the acquisition of a non-controlling interest is an equity transaction; no goodwill arises. A 45% non-controlling interest has been presented to date: The transaction is expected to be immediately accretive to Group core earnings per share.
• Returns: The investment is expected to further improve the return on invested capital (ROIC) already above Fresenius’ cost of capital after the integration, in line with the Group’s capital allocation criteria.
• Credit ratings: Fresenius is rated BBB (outlook positive) by S&P, Baa3 (outlook stable) by Moody’s and BBB- (outlook positive) by Fitch. A strong balance sheet and continued deleveraging remain priorities.

Guidance: No change to full-year 2026 guidance or to the 2030 Biopharma ambition of approximately doubling revenue compared with 2025 at an EBIT margin of around 20%.

Related Publications
The 31 March 2022 announcement of Fresenius Kabi’s acquisition of a 55% majority stake in mAbxience is available here, and the 1 August 2022 completion announcement here. The Biopharma ‘Meet the Management’ presentation of 15 December 2025 is available here.

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

Documents

Text as PDF document (PDF, 270 KB)

• Opening of new I.V. product lines in Kutno, Poland and Isola della Scala, Italy
• Combined investments of €54 million; more than €1 billion invested in European manufacturing over the past five years
• Fresenius further advances local-for-local approach and commitment to European patient care
   

Bad Homburg, Germany, September 25, 2026 – Fresenius is strengthening its European manufacturing network with new and expanded production capabilities for intravenous (IV) fluids in Poland and Italy. This week, the company opened a new IV fluids production line in Kutno, Poland, and expanded its manufacturing and warehouse infrastructure in Isola della Scala, Italy. Both sites play an important role in supplying European healthcare systems with essential medicines, helping ensure access for hospitals and patients across the region. Together representing investments of €54 million, the projects increase local production capacity, reinforce healthcare supply chains, and strengthen the availability of essential healthcare products across Europe.

Over the past five years, Fresenius has invested more than €1 billion in European production to enhance resilience and support healthcare systems. As a global healthcare company, Fresenius manufactures many of its products close to the patients it serves. The company operates around 20 manufacturing facilities and several research and development centers across Europe.

Healthcare systems face growing demand, increasing complexity, and rising expectations for reliable access. Through the continuous expansion and modernization of its manufacturing network, Fresenius is helping improve the availability of critical medicines, clinical nutrition products, and medical technologies for patients.

"Europe needs strong healthcare systems supported by resilient local manufacturing. With our investments in Poland and Italy, we are bringing essential production closer to patients and advancing our local-for-local approach, while at the same time strengthening security of supply. Healthcare is part of Europe’s security architecture, and resilient value chains are essential for greater sovereignty. This is #FutureFresenius in action: focused investments that create value for patients, customers and our businesses."
Dr. Marc-Alexander Mahl, President Pharma, Medical Nutrition & Sustainability

The projects also reflect the company’s disciplined approach to advancing its core businesses and growth platforms during the Rejuvenate phase of #FutureFresenius, Fresenius’ transformation and growth strategy. By directing capital toward manufacturing expansion, innovation, and operational excellence, Fresenius is enhancing its long-term competitiveness.

The projects complement Fresenius’ broader European investment plan, including a €400 million financing agreement signed with the European Investment Bank (EIB) in 2025 to support research and development activities as well as manufacturing expansion within the European Union.

As part of #FutureFresenius, the company will continue investing in the long-term growth and competitiveness of its businesses across (Bio)Pharma, Nutrition, and MedTech, helping improve supply chain security and access to essential medicines and healthcare products for patients around the world.
 

Contact

T +49 (0) 6172 686-4112
tim.kuehrt@fresenius.com

Documents

Text as PDF document (PDF, 112 KB)

• Opening of new I.V. product lines in Kutno, Poland and Isola della Scala, Italy
• Combined investments of €54 million; more than €1 billion invested in European manufacturing over the past five years
• Fresenius further advances local-for-local approach and commitment to European patient care

Fresenius is strengthening its European manufacturing network with new and expanded production capabilities for intravenous (IV) fluids in Poland and Italy. This week, the company opened a new IV fluids production line in Kutno, Poland, and expanded its manufacturing and warehouse infrastructure in Isola della Scala, Italy. Both sites play an important role in supplying European healthcare systems with essential medicines, helping ensure access for hospitals and patients across the region. Together representing investments of €54 million, the projects increase local production capacity, reinforce healthcare supply chains, and strengthen the availability of essential healthcare products across Europe.

Over the past five years, Fresenius has invested more than €1 billion in European production to enhance resilience and support healthcare systems. As a global healthcare company, Fresenius manufactures many of its products close to the patients it serves. The company operates around 20 manufacturing facilities and several research and development centers across Europe.

Healthcare systems face growing demand, increasing complexity, and rising expectations for reliable access. Through the continuous expansion and modernization of its manufacturing network, Fresenius is helping improve the availability of critical medicines, clinical nutrition products, and medical technologies for patients.

 "Europe needs strong healthcare systems supported by resilient local manufacturing. With our investments in Poland and Italy, we are bringing essential production closer to patients and advancing our local-for-local approach, while at the same time strengthening security of supply. Healthcare is part of Europe’s security architecture, and resilient value chains are essential for greater sovereignty. This is #FutureFresenius in action: focused investments that create value for patients, customers and our businesses."

Dr. Marc-Alexander Mahl, President Pharma, Medical Nutrition & Sustainability

The projects also reflect the company’s disciplined approach to advancing its core businesses and growth platforms during the Rejuvenate phase of #FutureFresenius, Fresenius’ transformation and growth strategy. By directing capital toward manufacturing expansion, innovation, and operational excellence, Fresenius is enhancing its long-term competitiveness.

The projects complement Fresenius’ broader European investment plan, including a €400 million financing agreement signed with the European Investment Bank (EIB) in 2025 to support research and development activities as well as manufacturing expansion within the European Union.

As part of #FutureFresenius, the company will continue investing in the long-term growth and competitiveness of its businesses across (Bio)Pharma, Nutrition, and MedTech, helping improve supply chain security and access to essential medicines and healthcare products for patients around the world.

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

Documents

Text as PDF document (PDF, 253 KB)

NutriChef launches in several European markets and combines real food ingredients¹ with the consistency and nutritional completeness of medical nutrition

• The launch of NutriChef, the fifth product launch within Fresenius’ Medical Nutrition portfolio in 2026, reflects the company’s commitment to patient-centered innovation-led growth and further strengthens its portfolio in nutritional care
• NutriChef expands Fresenius’ enteral nutrition offering with a real-food-based concept designed around the needs of patients, caregivers, and healthcare professionals
• Medical Nutrition is an attractive healthcare market supported by aging populations, increased demand for homecare, and growing awareness of the role of nutrition in patient care

Fresenius announced today the launch of NutriChef, a new enteral nutrition option that combines real food ingredients¹ such as fruit and vegetables while maintaining the nutritional completeness required for medical nutrition, in Germany, Switzerland, Norway, Netherlands, Denmark, and Sweden.

The product is designed to bridge the gap between conventional formula-based tube feeding and the familiarity associated with real meals and home-prepared foods. Available in three nutritionally complete, meal-inspired varieties², they contain ingredients derived from 21 different plants and more than 75 percent real food ingredients, including water and oils¹. The product provides high energy and protein as well as a blend of soluble and insoluble fibers.

“For many patients, the challenge is not only getting the nutrition they need. It is adapting to a new reality,” said Sebastien Guery, Executive Vice President Business Unit Medical Nutrition. “NutriChef responds to that need by combining familiar foods into enteral feeding with the safety, consistency and nutritional standards required in medical care. It is also a testament to the innovation-led growth of Fresenius, reflecting our ability to translate evolving patient needs into differentiated innovations and meaningful portfolio expansion.”

Developed for patients who require enteral nutrition, the new offering combines familiar food-based ingredients with the reliability and quality standards expected from medical nutrition. It offers patients, caregivers, and healthcare professionals an additional option that brings familiar food concepts into nutritional care.

As populations age and more care shifts beyond the hospital into outpatient and homecare settings, nutritional support is becoming increasingly important across healthcare systems. Fresenius continues to see strong long-term demand in Medical Nutrition, supported by demographic trends, growing awareness of disease-related malnutrition, and the need for solutions that fit into patients’ daily lives.

As the fifth addition to Fresenius’ Medical Nutrition portfolio introduced in 2026, NutriChef underscores the company’s continued investment in nutritional care across enteral and parenteral nutrition, the company continues to expand access to high-quality medical nutrition while addressing practical challenges faced by patients, caregivers, and healthcare professionals. As part of #FutureFresenius, the company continues to strengthen its portfolio with differentiated solutions that address evolving patient needs.

NutriChef is a food for special medical purposes for the dietary management of disease-related malnutrition, to be used under medical supervision. Product availability may vary by market.

NutriChef is essentially designed as an adult medical nutrition product, with limited, controlled use in:

• children >3 years (restricted)
• adolescents (possible full use only with medical supervision)

References
¹ Fresenius Kabi. NutriChef Ingredient List and Product Specification. Fresenius Kabi; 2026.
² Fresenius Kabi Market Research; Real Food & Tube Feeding Insights Study, 2022.

Contact

T +49 (0) 6172 686-2394
nicole.meier@fresenius.com

Documents

Text as PDF document (PDF, 118 KB)

NutriChef launches in several European markets and combines real food ingredients¹ with the consistency and nutritional completeness of medical nutrition

• The launch of NutriChef, the fifth product launch within Fresenius’ Medical Nutrition portfolio in 2026, reflects the company’s commitment to patient-centered innovation-led growth and further strengthens its portfolio in nutritional care
• NutriChef expands Fresenius’ enteral nutrition offering with a real-food-based concept designed around the needs of patients, caregivers, and healthcare professionals
• Medical Nutrition is an attractive healthcare market supported by aging populations, increased demand for homecare, and growing awareness of the role of nutrition in patient care

Fresenius announced today the launch of NutriChef, a new enteral nutrition option that combines real food ingredients¹ such as fruit and vegetables while maintaining the nutritional completeness required for medical nutrition, in Germany, Switzerland, Norway, Netherlands, Denmark, and Sweden. 

The product is designed to bridge the gap between conventional formula-based tube feeding and the familiarity associated with real meals and home-prepared foods. Available in three nutritionally complete, meal-inspired varieties², they contain ingredients derived from 21 different plants and more than 75 percent real food ingredients, including water and oils¹. The product provides high energy and protein as well as a blend of soluble and insoluble fibers.

“For many patients, the challenge is not only getting the nutrition they need. It is adapting to a new reality,” said Sebastien Guery, Executive Vice President Business Unit Medical Nutrition. “NutriChef responds to that need by combining familiar foods into enteral feeding with the safety, consistency and nutritional standards required in medical care. It is also a testament to the innovation-led growth of Fresenius, reflecting our ability to translate evolving patient needs into differentiated innovations and meaningful portfolio expansion.”

Developed for patients who require enteral nutrition, the new offering combines familiar food-based ingredients with the reliability and quality standards expected from medical nutrition. It offers patients, caregivers, and healthcare professionals an additional option that brings familiar food concepts into nutritional care.

As populations age and more care shifts beyond the hospital into outpatient and homecare settings, nutritional support is becoming increasingly important across healthcare systems. Fresenius continues to see strong long-term demand in Medical Nutrition, supported by demographic trends, growing awareness of disease-related malnutrition, and the need for solutions that fit into patients’ daily lives.

As the fifth addition to Fresenius’ Medical Nutrition portfolio introduced in 2026, NutriChef underscores the company’s continued investment in nutritional care across enteral and parenteral nutrition, the company continues to expand access to high-quality medical nutrition while addressing practical challenges faced by patients, caregivers, and healthcare professionals. As part of #FutureFresenius, the company continues to strengthen its portfolio with differentiated solutions that address evolving patient needs.

NutriChef is a food for special medical purposes for the dietary management of disease-related malnutrition, to be used under medical supervision. Product availability may vary by market.

NutriChef is essentially designed as an adult medical nutrition product, with limited, controlled use in:

• children >3 years (restricted)
• adolescents (possible full use only with medical supervision)

References

¹ Fresenius Kabi. NutriChef Ingredient List and Product Specification. Fresenius Kabi; 2026.
² Fresenius Kabi Market Research; Real Food & Tube Feeding Insights Study, 2022.

Contact

T +49 (0) 6172 686-2394
nicole.meier@fresenius.com

Documents

Text as PDF document (PDF, 83 KB)

Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL), a biosimilar to Rituxan®* (rituximab).¹

Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the biosimilar in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories.

"FDA approval of rituximab biosimilar represents an important milestone for Fresenius Kabi, further strengthening our U.S. biosimilars footprint with a well-established molecule that strategically complements our oncology and immunology portfolios. This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.

Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes. It is widely used in the treatment of adults with several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.²

The FDA approval is supported by a totality of the evidence approach, including analytical, non-clinical, and clinical data demonstrating that the product is highly similar to and has no clinically meaningful differences from the reference product, Rituxan^®, consistent with U.S. FDA requirements for biosimilar approval.

Biopharma is a core pillar of Fresenius' #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business covering the entire value chain, from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high-quality, affordable biologic therapies. The approval of the rituximab biosimilar represents another important step in strengthening Fresenius Kabi's growing biosimilars portfolio.

About Rituximab           

Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.

Rituximab is approved for the treatment of adults with several hematologic malignancies and autoimmune diseases in the United States, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).²

The rituximab biosimilar was developed and manufactured by Dr. Reddy's Laboratories. Fresenius Kabi holds exclusive commercialization rights in the United States.

The biosimilar development program was designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, pharmacokinetic, and clinical studies, in line with FDA requirements for biosimilar approval.

About Fresenius Kabi

Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company's broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home, reaching 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology; and intravenous generic drugs and fluids that advance essential patient care worldwide.

For more information, please visit www.fresenius-kabi.com.

About Fresenius

Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and numerous outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects.

For more information visit the Company’s website at www.fresenius.com.

Visit our media center: www.fresenius.com/media-center.

References

¹ U.S. Food and Drug Administration approval information for rituximab biosimilar developed by Dr. Reddy's Laboratories.

² Rituxan^® (rituximab) U.S. Prescribing Information. Rituxan® is a registered trademark of Genentech, Inc.

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

Documents

Text as PDF document (PDF, 83 KB)

Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL), a biosimilar to Rituxan®* (rituximab).¹

Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the biosimilar in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories.

"FDA approval of rituximab biosimilar represents an important milestone for Fresenius Kabi, further strengthening our U.S. biosimilars footprint with a well-established molecule that strategically complements our oncology and immunology portfolios. This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.

Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes. It is widely used in the treatment of adults with several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.²

The FDA approval is supported by a totality of the evidence approach, including analytical, non-clinical, and clinical data demonstrating that the product is highly similar to and has no clinically meaningful differences from the reference product, Rituxan®, consistent with U.S. FDA requirements for biosimilar approval.

Biopharma is a core pillar of Fresenius' #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business covering the entire value chain, from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high-quality, affordable biologic therapies. The approval of the rituximab biosimilar represents another important step in strengthening Fresenius Kabi's growing biosimilars portfolio.

About Rituximab            
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.

Rituximab is approved for the treatment of adults with several hematologic malignancies and autoimmune diseases in the United States, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).²

The rituximab biosimilar was developed and manufactured by Dr. Reddy's Laboratories. Fresenius Kabi holds exclusive commercialization rights in the United States.

The biosimilar development program was designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, pharmacokinetic, and clinical studies, in line with FDA requirements for biosimilar approval.

About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company's broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home, reaching 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology; and intravenous generic drugs and fluids that advance essential patient care worldwide.

For more information, please visit www.fresenius-kabi.com.

About Fresenius
Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and numerous outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects.

For more information visit the Company’s website at www.fresenius.com.
Visit our media center: www.fresenius.com/media-center.

References
¹ U.S. Food and Drug Administration approval information for rituximab biosimilar developed by Dr. Reddy's Laboratories.
² Rituxan® (rituximab) U.S. Prescribing Information. Rituxan® is a registered trademark of Genentech, Inc.
 

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

Documents

Text as PDF document (PDF, 127 KB)

Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration.

The applications were submitted by Polpharma Biologics S.A.¹, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.

“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”

PB016, in-licensed from Polpharma Biologics S.A.¹, is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. ^2,3 It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies.

The submissions for the intravenous presentation are supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval.

Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high quality, affordable biologic therapies. The FDA and EMA review acceptances represent the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position.

About vedolizumab
Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.⁴

It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, chronic inflammatory diseases that can significantly impact patients’ quality of life.

Vedolizumab is administered by intravenous infusion.

PB016 is being developed and manufactured by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval.

The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non‑clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).⁵

About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide.

For more information, please visit www.fresenius-kabi.com.

References 
1 Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026]
2 Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197–1205.
3 Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology, 16, 1-16.
4 Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437–44.
5 ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* (UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* | ClinicalTrials.gov [Last accessed: June 2026]

* Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company.
 

Contact

T +49 (0) 6172 686-2394
nicole.meier@fresenius.com

Documents

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Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration. 

The applications were submitted by Polpharma Biologics, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.

“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”

PB016, in-licensed from Polpharma Biologics S.A¹, is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The biosimilar candidate is being developed and manufactured by Polpharma, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.

Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. ^2,3 It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies.

The BLA submission for the intravenous presentation is supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval.

Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high quality, affordable biologic therapies. The FDA’s acceptance of the BLA represents the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position.

About vedolizumab

Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.⁴

It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, chronic inflammatory diseases that can significantly impact patients’ quality of life.

Vedolizumab is administered by intravenous infusion.

PB016 is being developed by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval.

The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non‑clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).⁵

About Fresenius Kabi

Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide.

For more information, please visit www.fresenius-kabi.com.

References 

¹ Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026]

² Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197–1205.

³ Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology, 16, 1-16.

⁴ Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437–44.

⁵ ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* (UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* | ClinicalTrials.gov [Last accessed: June 2026]

* Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company.

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-97033
nick.stone@fresenius.com

Fresenius today officially opened its new Innovation Center in Bad Homburg, Germany, marking a major milestone in strengthening research, development, and innovation in medical nutrition. The state-of-the-art laboratory, modern IT infrastructure and office facility accelerates new product development and drives innovation-led growth. In addition, it underscores Fresenius’ commitment to advancing patient care through science-based solutions and reinforces Europe as a key hub for healthcare.  

“With the new Innovation Center, we are further embedding science in our Fresenius campus in Bad Homburg, strengthening collaboration and enabling fast, integrated decision-making. This is a clear commitment to our mission of improving patients’ lives through high-quality, accessible medical nutrition.” emphasized Sara Hennicken, CFO of Fresenius, who is also responsible for real estate within the group, and host of the opening ceremony.

Under the guiding theme A New Chapter for Medical Nutrition, the new center will bring approximately 100 experts from multiple disciplines under one roof, fostering collaboration, execution excellence, and innovation. By consolidating previously decentralized teams, Fresenius is creating a highly integrated environment to accelerate the development of next-generation nutritional therapies.

Nutrition as a cornerstone of patient health

Medical nutrition plays a critical and often underrecognized role in patient outcomes. Particularly for individuals suffering from malnutrition, a condition that can significantly affect recovery, hospital stays, and overall quality of life. The Innovation Center will focus on advancing enteral nutrition solutions, including the development of products within the company’s portfolio designed to meet the needs of vulnerable patient populations. In parallel, it drives the development of automated pumping systems for patient-specific compounding of sterile ingredients into bags for parenteral nutrition (PN) solutions. This enables the preparation of tailored micro- and macronutrient PN admixtures while reducing the need for manual additions.

“Innovation is at the heart of everything we do,” said Dr. Marc-Alexander Mahl, President Pharma, Nutrition and Sustainability. “By combining scientific excellence with a deep understanding of patients’ needs, we are developing nutritional solutions that make a tangible difference in clinical practice and everyday life.”

At the center of the current strategic phase Rejuvenate is growth through innovation. The new facility embodies Fresenius’ broader ambition to translate scientific insights into practical healthcare solutions. As part of its long-term strategy, the company is investing in innovative platforms that bridge science and patient needs in line with #FutureFresenius.

With more than €50 million invested in the overall Bad Homburg campus in recent years, the Innovation Center adds to Fresenius’ ability to develop future-oriented therapies and contribute to resilient healthcare systems. It also demonstrates the continued commitment of Fresenius to its local-for-local approach not only when it comes to production but also in research and development.

Opening ceremony with distinguished participants

The opening ceremony brought together representatives from different functions, highlighting Fresenius leadership, research, and local government, including Sara Hennicken, CFO Fresenius, Alexander Hetjes, Mayor of Bad Homburg, Pierluigi Antonelli, CEO Fresenius Kabi, Dr. Marc-Alexander Mahl, President Pharma, Nutrition and Sustainability, and José Mainou, SVP R&D Enteral Nutrition Fresenius Kabi. Their presence highlighted the significance of the new center for both the company and the regional innovation ecosystem.

“Bad Homburg and Fresenius have been closely connected for decades,” said Mayor Alexander Hetjes. “The company plays a particularly significant role in shaping our city economically and as an employer. At the same time, Bad Homburg offers an environment in which innovation, growth, and international talent find ideal conditions. It is a strong signal that Fresenius is investing here at the Bad Homburg site in research, development, and future viability.”

A strong signal for the future

The new Innovation Center reflects Fresenius’ commitment to patient-centricity, operational excellence, and technological leadership. By investing in cutting-edge infrastructure and interdisciplinary collaboration, the company is strengthening its ability to shape the future of medical nutrition, directly benefiting patients, healthcare systems, and society as a whole.