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August 05, 2026
Bad Homburg, Germany
Member of various supervisory bodies
Chairman of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2021
Current term of office: 2025 – 2029


Date of Birth: | March 19, 1955 |
Place of Birth: | Bensberg |
Nationality: | German |
Professional Experience
2002 - 2018 | DZ Bank AG
|
2000 - 2002 | Deutsche Bank AG, Frankfurt Managing Director and Senior Credit Executive of the Corporates and Real Estate Division and CIB Corporate and Investment Bank |
1998 - 2000 | Deutsche Bank, Singapore General Manager and Chief Country Officer |
1981 - 1998 | Deutsche Bank AG, Düsseldorf and Frankfurt Various positions in corporate and investment banking |
Education/Academic career
1977 - 1981 | University of CologneStudies Business Administration (Diplom-Kaufmann) |
1975 - 1977 | Deutsche Bank AG Banking apprenticeship |
Membership of other statutory supervisory boards | |
B. Metzler seel. Sohn & Co. Aktiengesellschaft (Chair) | |
Membership of comparable German or foreign supervisory bodies | |
None |
Member of various supervisory bodies
Deputy Chairman of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2015
Current term of office: 2025 – 2029

Date of Birth: | December 23, 1954 |
Place of Birth: | Bielefeld |
Nationality: | German |
Professional Experience
2003 - 2015 | Allianz SE (formerly Allianz AG) Chairman of the Management Board |
1998 - 2003 | Allianz AG Member of the Management Board |
1988 - 1998 | Allianz Versicherungs-AG |
1983 - 1988 | Diekmann / Thieme GbR (Publishing House) CEO |
Education/Academic career
1973 - 1982 | University of Göttingen Studies of Law and Philosophy |
Membership of other statutory supervisory boards | |
Fresenius Management SE (Fresenius Group mandate) | |
Membership of comparable German or foreign supervisory bodies | |
None |
1 Stock listed company
Secretary of the Trade Union ver.di Vereinte Dienstleistungsgewerkschaft
Deputy Chair of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2020
Current term of office: 2025 – 2029

Date of Birth: | January 24, 1973 |
Place of BIrth: | Cottbus |
Nationality: | German |
Professional Experience
since 1991 | Trade Union Vereinte Dienstleistungsgewerkschaft ver.di
|
Education
1989 - 1991 | Lausitzer Braunkohle AG Apprenticeship as business management assistant |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German or foreign supervisory bodies | |
None |
Full-time Works Council Member
Helios Clinic Herzberg and Osterode GmbH
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2025
Current term of office: 2025 – 2029

Date of Birth: | August 03, 1963 |
Place of Birth: | Northeim |
Nationality: | German |
Professional Experience
2021 – 2026 | Member of the European Works Council of Fresenius SE & Co. KGaA
|
Since 2015 | Member of the Group Works Council Helios Kliniken GmbH
|
since 2014 | Helios Clinic Herzberg and Osterode GmbH
|
1998 – 2014 | Specialist nurse (from 1999) for nursing care in the surgical service Klinik Herzberg and Osterode GmbH (Rhön) |
1991 – 1998 | Nurse in the OR
|
4/83 – 03/91 | Temporary soldier
|
Education
1983 – 1986 | Training as a nurse |
1997 – 1999 | Training as a specialist nurse for nursing in the surgical service |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German or foreign supervisory bodies | |
None |
Chairman of the Board and Medical Director
of the Mainz University Medical Center
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2025
Current term of office: 2025 – 2029

Date of Birth: | May 14, 1970 |
Place of Birth: | Wiesbaden |
Nationality: | German |
Professional Experience
since 2024 | Mainz University Medical Center Chairman of the Board and Medical Director |
2021 – 2023 | Helios Dr. Horst Schmidt Kliniken Wiesbaden Medical Director |
2014 – 2021 | Helios Dr. Horst Schmidt Kliniken Wiesbaden Gastroenterology Clinic Director, Medical Director |
2012 – 2014 | St. Marienkrankenhaus Frankfurt Chief Physician for Internal Medicine and Gastroenterology |
2008 – 2012 | Mainz University Medical Center W2 Professorship for Gastrointestinal Endoscopy |
Education/Academic career
2005 | Mainz University Medical Center Habilitation |
1996 | Mainz University Medical Center Promotion |
1990 – 1996 | Mainz University Medical Center Studies of human medicine |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German and foreign supervisory bodies | |
None |
Full-time Works Council Member
Quirónsalud Hospital Universitari General de Catalunya
Senior trade union secretary of the UGT trade union
for the private healthcare sector Barcelona
Member of the Supervisory Board of Fresenius SE & Co. KGaA
First appointment: 2025
Current term of office: 2025 – 2029
Date of Birth: | May 25, 1984 |
Place of Birth: | Barcelona |
Nationality: | Spanish |
Professional Experience
since 2025 | Member of the European Works Council of Fresenius SE & Co. KGaA |
since 02/2024 | Mediator and Conciliator of the UGT trade union Labor Court of Catalonia Barcelona, Barcelona |
since 06/2020 | General Secretary of the UGT trade union UGT representative for occupational health and safety Quirónsalud Hospital Universitari General de Catalunya San Cugat del Vallés, Barcelon |
since 01/2006 | Administration Emergency Department Quirónsalud Hospital Universitari General de Catalunya San Cugat del Vallés, Barcelona |
Education/Academic career
2008 - 2010 | Master‘s degree in secretarial and operational management Vapor Universitario de Terrassa, Barcelona |
2006 - 2008 | CFGS Administration and Finance IES Terrassa, Barcelona |
2004 - 2005 | CFGM Administrativa IES Santa Eulalia, Barcelona |
1996 - 2000 | Secondary school diploma I.E.S. Cavall Bernat, Barcelona |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German and foreign supervisory bodies | |
None |
Member of various supervisory bodies
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2016
Current term of office: 2025 – 2029

Date of Birth: | November 17, 1960 |
Place of Birth: | Offenbach / Main |
Nationality: | German |
Professional Experience
2008 - 2024 | UCB S.A. Chief Medical Officer and Executive Vice President Development |
2001 - 2009 | Schwarz Pharma AG Member of the Executive Board, Head of Research and Development |
2000 - 2001 | BASF Pharma Vice President Global Projects |
1992 - 2000 | Hoechst AG Various positions, last serving as Vice President Clinical Development |
Education/Academic career
since 2000 | University of Frankfurt am Main Professor for Internal Medicine |
1985 | University of Frankfurt am Main Doctorate in medicine (Dr. med.) |
1979 - 1985 | University of Frankfurt am Main Studies of medicine |
Membership of other statutory supervisory boards | |
Evotec SE1 (Chair) | |
Membership of comparable German or foreign supervisory bodies | |
Sobi Swedish Orphan Biovitrum1 (Member of the Board of Directors) |
1 Stock listed company
Full-time Works Council Member
Fresenius Kabi Deutschland GmbH
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2023
Current term of office: 2025 – 2029

Date of Birth: | May 18, 1969 |
Place of Birth: | Marburg |
Nationality: | German |
Professional Experience
since 2002 | Fresenius Kabi Deutschland GmbH, Standort Friedberg
|
since 2021 | Honorary Judge, Hessian Tax Court |
since 2017 | IHK-Examiner, IHK Frankfurt |
since 2015 | Honorary Judge, Labour Court |
2007 – 2018 | Laboratoy Manager, IPK-Laboratories |
2003 – 2007 | Quality Control Technician |
1992 – 2003 | Quality Control Laboratory Assistant |
Education
2021 | Specialist for Occupational Health Management, IHK |
2020 – 2021 | Certified Specialist for Data Protection and Data Security |
2018 | Project Manager, IHK |
1999 – 2001 | Training as Bachelor Professional of Management for Industry |
1985 – 1989 | Apprenticeship as Chemical Laboratory Technician |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German or foreign supervisory bodies | |
None |
Works Council Member
Fresenius Kabi España S.A.U.
Laboratory Technician for the Pharmaceutical Industry
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2016
Current term of office: 2025 – 2029

Date of Birth: | January 29, 1974 |
Place of Birth: | Barcelona |
Nationality: | Spanish |
Professional Experience
since 2026 | Chair of the European Works Council of Fresenius SE & Co. KGaA |
since 2020 | Spokesman of the works council for the company equal opportunities and equal opportunities plan (Plan de Igualdad) |
since 2016 | Member of the Supervisory Board of Fresenius SE & Co. KGaA |
since 2008 | Member of the European Works Council of Fresenius SE & Co. KGaA |
since 2004 | Member of the Works Council Fresenius Kabi España S.A.U. |
since 1998 | Laboratory Technician for Pharmaceutical Products at Fresenius Kabi España S.A.U |
Education
Since 2024 | Further education and training on CSRD and sustainability, including analysis of reports on a company‘s environmental, social and ethical performance; Trade union action for ecological transition and energy transition, JMZ Trade Union University |
Since 2020 | Further education and training on the topic of the Gender Equality and Equal Opportunities Plan according to Ley Orgánica 3/2007, with a focus on rules for pay transparency, gender equality audits and reporting obligations |
1998 | Training as a laboratory technician in the pharmaceutical industry Fresenius Kabi España S.A.U. |
1990 - 1994 | Secondary school graduation Instituto Cristófol Ferrer, Secondary school |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German and foreign supervisory bodies | |
None |
Full-time Works Council Member
Helios Klinikum Krefeld GmbH
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2026
Current term of office: 2026 – 2029

Date of Birth: | February 13,, 1971 |
Place of Birth: | Dessau |
Nationality: | German |
Professional Experience
since 03/2025 | Member of the European Works Council of Fresenius SE & Co. KGaA
|
since 05/2022 | 2nd Deputy Chair of the Works Council of Helios Klinikum Krefeld GmbH |
since 05/2014 | Member of the Group Works Council Helios Kliniken GmbH
|
since 07/1995 | Employee Cäcilien-Hospital Krefeld-Hüls
|
Education
1994 – 1995 | Social Service at Cäcilien-Hospital Krefeld-Hüls |
1987 – 1990 | Apprenticeship as an Electrician |
Membership of other statutory supervisory boards | |
None | |
Membership of comparable German or foreign supervisory bodies | |
None |
Member of various supervisory bodies
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2022
Current term of office: 2025 – 2029

Date of Birth: | February 28, 1961 |
Place of Birth: | Marl |
Nationality: | German |
Professional Experience
2014 – 2021 | LPEQ Ltd. (Listed Private Equity Association), London Member of the Board, Non Executive Director |
2012 - 2022 | Deutsche Beteiligungs AG, Frankfurt / Main Member of the Executive Board / Chief Financial Officer Responsible for Finance and Accounting, Investor Relations, Legal and Tax, Portfolio Valuation, Risk Management, Internal Audit, Human Resources, Organization, IT (incl. cybersecurity) |
2011 – 2012 | Kirche in Not, Königstein im Taunus Managing Director at the global headquarter of the organization |
1990 – 2011 | KPMG AG, Frankfurt / Main Last position: Partner
|
1987 - 1990 | Winterhager Dr. Heintges Stützel Laubach GmbH, Wirtschaftsprüfungsgesellschaft, Düsseldorf Last position: Auditor and tax specalist |
Education/Academic career
1995 | Appointment as auditor (2013 waiver of appointment) |
1992 | Appointment as tax advisor (2022 waiver of appointment) |
1980 - 1987 | Westfälische Wilhelms-Universität Münster
|
Membership of other statutory supervisory boards | |
Fresenius Management SE (Fresenius Group mandate) | |
Membership of comparable German and foreign supervisory bodies | |
None |
Member of various supervisory bodies
Member of the Supervisory Board of Fresenius SE & Co. KGaA
Initial appointment: 2022
Current term of office: 2025– 2029

Date of Birth: | April 13, 1961 |
Place of Birth: | Stuttgart |
Nationality: | German |
Professional Experience
2018 – 2022 | Siemens Healthineers AG, Erlangen Member of the Managing Board Responsible for Imaging, Advanced Therapies, Technology & Innovation, Quality & Regulatory Affairs, Sustainability |
2018 – 2019 | Siemens Healthineers AG, Erlangen President Business Segment Diagnostic Imaging |
2015 – 2018 | Siemens AG, Healthcare Sector, Erlangen SVP, General Manager of Business Line Magnetic Resonance |
2014 – 2015 | Beckmann-Coulter – A Danaher Company, Miami (USA) SVP, Head of Business Unit Hematology and Urinalysis |
1998 – 2014 | Siemens AG, Healthcare Sector, Knoxville (USA)
|
2012 – 2014 | Siemens AG, Healthcare Sector, Knoxville (USA) CEO PETNET Solutions (Radiopharmaceuticals) |
1994 – 1998 | University of Tübingen Resident Physician Surgery |
1993 – 1994 | University of Frankfurt am Main Resident Physician Internal Medicine, Nuclear Medicine |
Education/Academic career
1995 | University Frankfurt am Main Doctor of Medicine, M.D. (Dr.) |
1985 – 1992 | University Frankfurt am Main Studies in Medicine |
Membership of other statutory supervisory boards | |
Gerresheimer AG1 | |
Membership of comparable German and foreign supervisory bodies | |
None |
1 Stock listed company
Wolfgang Kirsch (Chair)
Michael Diekmann
Susanne Zeidler
Susanne Zeidler (Chair)
Grit Genster
Carsten Georg
Wolfgang Kirsch
Dr. Christoph Zindel
Dr. Dieter Schenk (Chair)
Michael Diekmann
Wolfgang Kirsch
Susanne Zeidler
The committee consists equally of two members each of the Supervisory Board of Fresenius SE & Co. KGaA and of Fresenius Management SE.
Dr. Christoph Zindel (Chair)
Óscar Romero de Paco
Susanne Zeidler
Rules of Procedure
Rules of Procedure
CVs of the Supervisory Board members
Meeting participation by individual
Chairman of the Supervisory Board of Fresenius SE & Co. KGaA
Former Chief Executive Officer of Deutsche Post DHL Group
Member of various Supervisory Boards
Member of various Supervisory Boards
Deputy Chairman
Member of supervisory bodies
Member of supervisory bodies
Contact
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.
August 19, 2026
Copenhagen, Denmark / Stockholm, Sweden
August 19 – 20, 2026
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
August 05, 2026
Bad Homburg, Germany
Fresenius is further expanding its access to innovation networks through its own corporate venture capital fund. Fresenius Ventures invests in founders, technologies, and business models from early financing rounds through to the growth stage. The newly established unit combines venture capital with medical, regulatory, and operational expertise and provides access to clinical, scientific, and academic networks.
With an intended investment volume of more than €200 million over the next 5 years, Fresenius Ventures targets growth fields adjacent to Fresenius’ existing strategic platforms (Bio)Pharma, MedTech, and Care Provision. Potential investment areas of Fresenius Ventures include, for example, precision nutrition, microbiome research, new modalities, and digital care provision solutions. Investments will be made in line with Fresenius’ capital allocation approach.
Michael Sen, CEO of Fresenius, says: “Fresenius Ventures is a strategic instrument of #FutureFresenius. Through targeted investments in promising healthcare innovators, we gain early access to breakthrough technologies, new ideas, and entrepreneurial talent. This step enables us to strengthen our innovation capabilities within the healthcare ecosystem and tap into adjacent growth fields while consistently strengthening Fresenius. I am delighted that Dr. Thomas Michael Thestrup, a highly experienced healthcare and corporate venture capital expert, will lead Fresenius Ventures.”
Thomas Michael Thestrup joins Fresenius from Angelini Ventures, an international healthcare venture capital company and part of the Italian industrial group Angelini Industries.
“Fresenius Ventures backs the innovators shaping the next era of healthcare with the experience, pace, and conviction founders expect. We offer more than capital: deep operating and regulatory expertise across global markets, coupled with access to the clinical, scientific, and academic ecosystems where real progress happens today,” says Thomas Thestrup, Managing Director and Head of Fresenius Ventures.
Thomas Thestrup has more than 15 years of experience in research, health tech, and the pharma industry. Prior to Angelini Ventures, he worked for Lundbeck A/S as Director of Corporate Business Development and Strategy. Further positions prior to this include Global Business Development at UCB as well as Life Science Ventures at Sunstone Capital. Thomas Thestrup received his Ph.D. from the Max Planck Institute of Neurobiology in Munich.
For more information about Fresenius Ventures, please see: fresenius- ventures.com
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 is further expanding its access to innovation networks through its own corporate venture capital fund. Fresenius Ventures invests in founders, technologies, and business models from early financing rounds through to the growth stage. The newly established unit combines venture capital with medical, regulatory, and operational expertise and provides access to clinical, scientific, and academic networks.
With an intended investment volume of more than €200 million over the next 5 years, Fresenius Ventures targets growth fields adjacent to Fresenius’ existing strategic platforms (Bio)Pharma, MedTech, and Care Provision. Potential investment areas of Fresenius Ventures include, for example, precision nutrition, microbiome research, new modalities, and digital care provision solutions. Investments will be made in line with Fresenius’ capital allocation approach.
Michael Sen, CEO of Fresenius, says: “Fresenius Ventures is a strategic instrument of #FutureFresenius. Through targeted investments in promising healthcare innovators, we gain early access to breakthrough technologies, new ideas, and entrepreneurial talent. This step enables us to strengthen our innovation capabilities within the healthcare ecosystem and tap into adjacent growth fields while consistently strengthening Fresenius. I am delighted that Dr. Thomas Michael Thestrup, a highly experienced healthcare and corporate venture capital expert, will lead Fresenius Ventures.”
Thomas Michael Thestrup joins Fresenius from Angelini Ventures, an international healthcare venture capital company and part of the Italian industrial group Angelini Industries.
“Fresenius Ventures backs the innovators shaping the next era of healthcare with the experience, pace, and conviction founders expect. We offer more than capital: deep operating and regulatory expertise across global markets, coupled with access to the clinical, scientific, and academic ecosystems where real progress happens today,” says Thomas Thestrup, Managing Director and Head of Fresenius Ventures.
Thomas Thestrup has more than 15 years of experience in research, health tech, and the pharma industry. Prior to Angelini Ventures, he worked for Lundbeck A/S as Director of Corporate Business Development and Strategy. Further positions prior to this include Global Business Development at UCB as well as Life Science Ventures at Sunstone Capital. Thomas Thestrup received his Ph.D. from the Max Planck Institute of Neurobiology in Munich.
For more information about Fresenius Ventures, please see: fresenius-ventures.com
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