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.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
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.
Fresenius (XFRA: FRE, OTC: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually.
With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
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.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually.
With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.comand follow Fresenius Investor Relations on LinkedIn.
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.
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.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
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.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually. With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch
New ready-to-use three-chamber bag parenteral nutrition solution strengthens Fresenius’ global clinical nutrition portfolio and reflect its commitment to patient centric innovation
Fresenius, a global healthcare company, today announced the European launch of the Pedismof® range, a new ready to use three chamber bag for pediatric parenteral nutrition. Developed by Fresenius Kabi, the introduction marks an important milestone within the clinical nutrition portfolio and aligns with the Company’s #FutureFresenius strategy to foster patient centric innovation, simplify care, and support patient access to essential therapies.
The range offers age-specific formulations for preterm and term neonates, infants, children, and adolescents, supporting standardized pediatric parenteral nutrition. It is the third product launch this year in the company’s clinical nutrition branch.
The three chamber bag combines glucose, amino acids with a balanced profile, and the lipid emulsion SMOFlipid®, which contains fish oil and omega 3 fatty acids. The formulation has been developed in line with established European pediatric nutrition guidelines1 and is available in multiple volumes to meet the nutritional requirements of most patients.
“The Pedismof® range is an example of how our clinical nutrition portfolio continues to evolve to address specific clinical and patient needs,” said Dr. Marc Alexander Mahl, President Pharma, Nutrition and Sustainability at Fresenius Kabi. “With age appropriate formulations and a ready to use design, we aim to support healthcare professionals in the delivery of neonatal and pediatric parenteral nutrition within established clinical frameworks.”
Just a few days ago – on June 2nd, Fresenius opened an Innovation Center in Germany focused specifically on clinical nutrition. The new center will bring approximately 100 experts from multiple disciplines under one roof, fostering collaboration and speed to continuously develop new products.
This launch is a further proof point of the company’s current strategy phase Rejuvenate by strengthening Fresenius’ clinical nutrition portfolio and underscores the Company’s focus on scalable, system relevant therapies that contribute to long term patient access and differentiated health outcomes.
Availability of Pedismof® range may vary by country and are subject to local regulatory approvals.
1Van Goudoever JB et al. Clin Nutr. 2018;37(6 Pt B):2315-2323. Lapillonne A et al. Clin Nutr. 2018;37(6 Pt B):2324-2336. Joosten K et al. Clin Nutr. 2018;37(6 Pt B):2309-2314. Mesotten D et al. Clin Nutr. 2018;37(6 Pt B):2337-2343. Mihatsch W et al. Clin Nutr. 2018;37(6 Pt B):2360-2365. Jochum F et al. Clin Nutr. 2018;37(6 Pt B):2344-2353.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually. With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch
New ready-to-use three-chamber bag parenteral nutrition solution strengthens Fresenius’ global clinical nutrition portfolio and reflect its commitment to patient centric innovation
Fresenius, a global healthcare company, today announced the European launch of the Pedismof® range, a new ready to use three chamber bag for pediatric parenteral nutrition. Developed by Fresenius Kabi, the introduction marks an important milestone within the clinical nutrition portfolio and aligns with the Company’s #FutureFresenius strategy to foster patient centric innovation, simplify care, and support patient access to essential therapies.
The range offers age-specific formulations for preterm and term neonates, infants, children, and adolescents, supporting standardized pediatric parenteral nutrition. It is the third product launch this year in the company’s clinical nutrition branch.
The three chamber bag combines glucose, amino acids with a balanced profile, and the lipid emulsion SMOFlipid®, which contains fish oil and omega 3 fatty acids. The formulation has been developed in line with established European pediatric nutrition guidelines1 and is available in multiple volumes to meet the nutritional requirements of most patients.
“The Pedismof® range is an example of how our clinical nutrition portfolio continues to evolve to address specific clinical and patient needs,” said Dr. Marc Alexander Mahl, President Pharma, Nutrition and Sustainability at Fresenius Kabi. “With age appropriate formulations and a ready to use design, we aim to support healthcare professionals in the delivery of neonatal and pediatric parenteral nutrition within established clinical frameworks.”
Just a few days ago – on June 2nd, Fresenius opened an Innovation Center in Germany focused specifically on clinical nutrition. The new center will bring approximately 100 experts from multiple disciplines under one roof, fostering collaboration and speed to continuously develop new products.
This launch is a further proof point of the company’s current strategy phase Rejuvenate by strengthening Fresenius’ clinical nutrition portfolio and underscores the Company’s focus on scalable, system relevant therapies that contribute to long term patient access and differentiated health outcomes.
Availability of Pedismof® range may vary by country and are subject to local regulatory approvals.
1Van Goudoever JB et al. Clin Nutr. 2018;37(6 Pt B):2315-2323. Lapillonne A et al. Clin Nutr. 2018;37(6 Pt B):2324-2336. Joosten K et al. Clin Nutr. 2018;37(6 Pt B):2309-2314. Mesotten D et al. Clin Nutr. 2018;37(6 Pt B):2337-2343. Mihatsch W et al. Clin Nutr. 2018;37(6 Pt B):2360-2365. Jochum F et al. Clin Nutr. 2018;37(6 Pt B):2344-2353.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually. With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch
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.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually. With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch
Fresenius Kabi, an operating company of Fresenius, has entered a first-of-its-kind partnership with U.S. manufacturer Phlow Corp. to establish a fully domestic, end-to-end supply chain for Epinephrine Injection, USP — an FDA designated essential medicine frequently at risk of shortage in the United States.
Under the collaboration, Phlow will produce the U.S.-based API, while Fresenius Kabi manufactures the finished doses for hospitals and clinics across the country. With this initiative, Fresenius advances its local-for-local manufacturing strategy and supports national efforts to strengthen pharmaceutical security. The partnership reinforces the ambitions of #FutureFresenius as it expands Fresenius’ role as a leading global provider of lifesaving therapies, advancing resilient manufacturing that improves patient care and health-system stability.
Pending regulatory approvals, epinephrine produced through this collaboration could be available to U.S. hospitals in 2027.
Fresenius Kabi, an operating company of Fresenius, has entered a first-of-its-kind partnership with U.S. manufacturer Phlow Corp. to establish a fully domestic, end-to-end supply chain for Epinephrine Injection, USP — an FDA designated essential medicine frequently at risk of shortage in the United States.
Under the collaboration, Phlow will produce the U.S.-based API, while Fresenius Kabi manufactures the finished doses for hospitals and clinics across the country. With this initiative, Fresenius advances its local-for-local manufacturing strategy and supports national efforts to strengthen pharmaceutical security. The partnership reinforces the ambitions of #FutureFresenius as it expands Fresenius’ role as a leading global provider of lifesaving therapies, advancing resilient manufacturing that improves patient care and health-system stability.
Pending regulatory approvals, epinephrine produced through this collaboration could be available to U.S. hospitals in 2027.