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Members of the Supervisory Board of Fresenius SE & Co. KGaA

Member of various supervisory bodies

Chairman of the Supervisory Board of Fresenius SE & Co. KGaA

Initial appointment: 2021
Current term of office: 2025 – 2029

Wolfgang Kirsch

Date of Birth:

March 19, 1955

Place of Birth:

Bensberg

Nationality:

German

Professional Experience

2002 - 2018

DZ Bank AG

  • 2006 - 2018 Chief Executive Officer
  • 2005 - 2006 Deputy Chief Executive Officer
  • 2002 - 2005 Member of the Board of Managing Directors

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)
Fresenius Management SE (Fresenius Group mandate, Chair)
Würth Finance International B.V.

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

Michael Diekmann

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

Grit Genster

Date of Birth:

January 24, 1973

Place of BIrth:

Cottbus

Nationality:

German

Professional Experience

since 1991

Trade Union Vereinte Dienstleistungsgewerkschaft ver.di

  • since 2015      Head of Health care affairs
  • 2012 – 2015    Department coordination
  • 1996 – 2012    ver.di-districts Essen und Wuppertal-Niederberg
    last position serving as managing director
  • 1994 – 1996    Trainee as trade union secretary
  • 1991 – 1994    Administrative clerk

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

Carsten Georg

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

  • 2023 – 2026 Member of the Executive Committee

Since 2015

Member of the Group Works Council Helios Kliniken GmbH

  • Since 06/2026 Chair of the Group Works Council
  • 2019 – 2026 Deputy Chair of the Group Works Council

since 2014

Helios Clinic Herzberg and Osterode GmbH

  • Works Council member released from duties since 2022 (Chair)
  • Specialist nurse for nursing care in the surgical service

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

  • Osterode am Harz District Hospital / Herzberg Department
  • District of Osterode am Harz

4/83 – 03/91

Temporary soldier

  • During this time training as a nurse

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

Ralf Kiesslich

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) 
Financière de Tubize1

  • 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

Holger Michel

Date of Birth:

May 18, 1969

Place of Birth:

Marburg

Nationality:

German

Professional Experience

since 2002

 Fresenius Kabi Deutschland GmbH, Standort Friedberg

  • since 2022 Chairman Works Council
  • 2021 – 2026 Member of the European Works Council of Fresenius SE & Co. KGaA
  • since 2018 Deputy Chairman
  • since 2002 Member of the Works Council

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

Oscar Romero de Paco

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 2026 Member of the Executive Committee

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 2026 Deputy Chair of the Group Works Council
  • since 2022 Member of the Group Works Committee
     

since 07/1995

Employee Cäcilien-Hospital Krefeld-Hüls

  • since 2018 Full-time Works Council Member
  • 2006 – 2018 Deputy Chair of the Works Council
  • since 1998 Member of the Works Council

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

Susanne Zeidler

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

  • 2005 – 2010 Audit Services / Audit of private hospital chain and non-profit organizations
  • 2000 – 2005 Head of the report critique and of administrative areas
  • 1990 – 2005 Corporate finance / Company valuations in various industries and different business models

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

  • 1987 Degree: Diplom Kaufmann (Business Administration)
  • 1981 - 1987 Business Administration
  • 1980 - 1981 Education studies in Latin and French

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 CEO PETNET Solutions (Radiopharmaceuticals),
    Knoxville (USA)
  • 1998 – 2012 Various leading positions:
    Marketing, R & D, Erlangen

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

Committees of the Supervisory Board of Fresenius SE & Co. KGaA

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

Additional information on the Supervisory Board of Fresenius SE & Co. KGaA

Members of the Supervisory Board of Fresenius Management SE

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

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.

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

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

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

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

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

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

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

 

About vedolizumab

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

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

Vedolizumab is administered by intravenous infusion.

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

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

About Fresenius Kabi

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

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

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

 

References 

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

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

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

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

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

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

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

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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

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