Fresenius

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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News

  • Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate

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    May 26, 2026 · Fresenius

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    Michael Sen, CEO of Fresenius, emphasized: “In the past financial year, we showed that Fresenius can deliver a strong performance even in an environment where volatility has become the norm.”

    May 22, 2026 · Fresenius

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    May 06, 2026 · Fresenius

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    May 06, 2026 · Fresenius

  • #FutureFresenius is paying off: S&P Global Ratings revises outlook for Fresenius SE from stable to positive

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    April 08, 2026 · Fresenius

  • Brief News

    Fresenius publishes 2025 Annual Report – REJUVENATE: Delivering accelerated performance for long-term value creation

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    March 25, 2026 · Fresenius

    #FutureFresenius: REJUVENATE in action – Delivering accelerated performance for long-term value creation; 2025 yet another year of strong delivery

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  • Fresenius Supervisory Board extends ahead of schedule CEO Michael Sen’s contract by five years --- Christian Pawlu to join Management Board for Fresenius Helios effective July 1, 2026

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    February 25, 2026 · Fresenius

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    January 14, 2026 · Fresenius Kabi

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    The sale of the Austrian project business and spa operations of VAMED Vitality World to PORR, announced by Fresenius in October 2025, has received the necessary approvals and will be completed on December 31, 2025. 

     

    December 23, 2025 · Fresenius

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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

Meet AskFRE!

AskFRE is the AI powered Investor Relations assistant from Fresenius, designed to make capital markets information easier and faster to access.

Integrated directly into each Investor Relations subpage, AskFRE allows you to ask questions in natural language and receive direct answers on financial results, company updates and other Investor Relations topics – available 24/7.

All responses are based exclusively on publicly available Fresenius disclosures.

By providing a faster and more intuitive way to navigate financial information, AskFRE supports transparent, timely and user focused communication – and enhances the overall digital Investor Relations experience at Fresenius.

You can access AskFRE on each Investors subpage by clicking the chatbot icon in the lower right corner of your screen.
 

What you need to know

  • Languages: Available in English and German (use the standard language switch in the top right corner of the website)
  • Coverage: Information from the last five years up to today
  • Sources: Each answer includes the exact source reference (e.g. document and page number)
  • Data basis: Only publicly available content from the Fresenius Investor Relations website (HTML pages and PDF documents)
  • Data protection: Please access all information here. 

Important notice: AI generated responses may be incomplete or contain inaccuracies. For more information, please refer to the Terms of Use.

Feedback: Suggestions for improvement, missing content or functional issues – please contact us at ir-fre@fresenius.com.

 

How to use AskFRE

To get the most accurate results, we recommend:

  • Ask precise questions, including a specific topic and, if relevant, a time frame
  • Use the source links provided to directly access the underlying documents (e.g. Annual Reports or presentations)
  • Refine your question if the answer is too broad or not specific enough 

 

Try some of these example questions to interact with AskFRE:

  • What is #FutureFresenius about?
  • What are the main business updates from the Fresenius Q1 2026 results?
  • How many hospitals does Fresenius Helios operate in Germany?

 

Contact

Nick Stone

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

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International financial analysts cover Fresenius SE & Co. KGaA and publish reports and updates on the development of its business and its shares. Once a quarter, VARA Research creates an up-to-date consensus from these various forecasts. An interactive and downloadable set of the consensus data for Fresenius SE & Co. KGaA can be found on Vara Research.           

Contact

Florian Feick

Vice President Investor Relations
Deputy Head of Investor Relations
T: +49 (0) 6172 608-5167
florian.feick@fresenius.com

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Related Links

Interactive Tool

Library

Fresenius Investor Presentation (PDF, 1.77 MB)
Conference Call Q2 2026

August 05, 2026
Bad Homburg, Germany

Conference Call Q2 2026

Webcast
Import (ICS)

Next event

FAQ

Shares and dividends
Conference Call Q2 2026

August 05, 2026
Bad Homburg, Germany

Conference Call Q2 2026

Webcast
Import (ICS)

Next event

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