- Exclusive option rights for up to 37 potential first-to-market biosimilar candidates to significantly expand Fresenius’ portfolio from 29 marketed and pipeline molecules today to up to 66 in the next decade, addressing more than €370 billion in originator sales; the largest development agreement announced in the biosimilars industry to date.
- Agreement gives Fresenius full strategic flexibility to select and advance biosimilar candidates to develop, against its established selection criteria, while retaining full commercialization economics of products under the agreement.
- Fresenius will determine the long-term manufacturing strategy for each candidate, with optionality to leverage the mAbxience network, wholly owned since October 2026.
- The next-generation portfolio spans 13 therapeutic areas and multiple biologic technologies, including monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins.
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) today announced that it has entered an exclusive development agreement with WuXi Biologics (2269.HK), a leading global contract organization for research, development and manufacturing. WuXi Biologics brings proven large-scale biologics development and manufacturing capability, a track record across monoclonal and bispecific antibodies and antibody-drug conjugates, and a worldwide network spanning Europe, the United States, China and Singapore. The agreement significantly expands and accelerates Fresenius’ biosimilars pipeline while preserving strategic flexibility and disciplined capital allocation. It provides access to a scalable pathway to increase the portfolio from 29 marketed and pipeline molecules today to up to 66 molecules, addressing more than €370 billion in originator list-price-based-sales, extending Biopharma growth in the long term beyond its 2030 ambition.
The agreement provides Fresenius with exclusive access to up to 37 identified biosimilar candidates over the next decade, making it the largest development agreement announced in the biosimilars industry to date. Development programs will be selected and advanced against Fresenius’ established selection criteria, based on market attractiveness, development risk, and expected returns. Fresenius will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product under the agreement.
Michael Sen, Chief Executive Officer of Fresenius, said: “We are doubling down on our Biopharma business. With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence. It provides a disciplined, scalable way to potentially triple our portfolio while retaining economic ownership, strategic control and the flexibility to allocate capital to the most compelling opportunities. Combined with the full ownership of mAbxience, this fuels our Biopharma growth well beyond 2030.”
The next-generation portfolio is expected to span 13 therapeutic areas, including expanding into neurology, nephrology and cardiopulmonary, while further strengthening Fresenius’ established positions in oncology, immunology, and gastroenterology. It will encompass multiple biologic technologies, including monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins. Initial development is expected to focus on polatuzumab vedotin, an antibody-drug conjugate for the treatment of diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for the treatment of thyroid eye disease.
The agreement forms part of a balanced pipeline expansion strategy through internal R&D, targeted collaboration, and selective in-licensing. It gives Fresenius privileged access to the rapidly advancing biotech landscape worldwide and combines this with Fresenius’ global manufacturing and commercialization network. Development activities are expected to be conducted using WuXi Biologics’ global network. Building on the recent acquisition of Spain-headquartered mAbxience, the agreement significantly expands the funnel of potential development candidates for Fresenius’ wholly owned platform, enabling greater value capture across the development, manufacturing and commercialization value chain.
Financial Considerations
Fresenius’ full-year 2026 guidance remains unchanged, and the Company confirms the 2030 Biopharma ambition announced in December 2025 of – approximately doubling Biopharma revenue compared with 2025 at an EBIT margin of around 20% – which relates to the existing marketed and late-stage portfolio. The agreement is additive, expanding the opportunity beyond 2030, and, as a result, Fresenius expects to raise its long-term Biopharma ambitions significantly.
Under the terms of the agreement, Fresenius will compensate WuXi Biologics on a fee-for-service basis for each biosimilar candidate that Fresenius selects for development. Research and development investment scales only as selected programs progress, with each option exercised against Fresenius’ established selection criteria (market attractiveness, development risk, and expected returns). Fresenius will determine the long-term manufacturing strategy for each biosimilar candidate, including the potential progressive transfer of selected products to mAbxience. Fresenius will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product under the agreement.
As selected candidates advance, Biopharma research and development expenditure and profitability will correspondingly reflect the increased level of investment during the development phase, ahead of future revenue and profitability growth.
The agreement fits within Fresenius’ unchanged financial framework, with continued priority on a strong balance sheet and further deleveraging; it is funded from operating cash flow and requires no new financing. Fresenius is rated BBB with a positive outlook by S&P, Baa3 with a stable outlook by Moody’s, and BBB- with a positive outlook by Fitch.
Related Publications
The 1 October 2026 announcement of Fresenius' acquisition of the remaining 45% of mAbxience is available here. The 31 March 2022 announcement of Fresenius Kabi's acquisition of a 55% majority stake in mAbxience is available here, and the 1 August 2022 completion announcement here. The Biopharma 'Meet the Management' presentation of 15 December 2025 is available here.
About polatuzumab vedotin
Polatuzumab vedotin is an antibody-drug conjugate (ADC) marketed under the brand name Polivy® for the treatment large B-cell lymphoma (DLBCL), the most common subtype of non-Hodgkin lymphoma.1
Globally, DLBCL accounts for approximately one-third of non-Hodgkin lymphomas.² In 2024, more than 562,000 new cases of non-Hodgkin lymphoma were diagnosed worldwide, with approximately 235,000 deaths attributed to the disease.3
The polatuzumab vedotin ADC comprises a monoclonal antibody directed against CD79b, a protein expressed on B cells including DLBCL cells, linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) through a cleavable linker. Following binding to CD79b, the ADC is internalized and MMAE is released, disrupting microtubules and leading to cell death.1
Polivy® is administered by intravenous infusion and is a registered trademark of Genentech, Inc.
About teprotumumab
Teprotumumab is a human monoclonal antibody marketed under the brand name Tepezza® for the treatment of thyroid eye disease (TED), a rare autoimmune condition associated with Graves' disease.4 TED is estimated to affect approximately 16 women and 3 men per 100,000 people annually, with around 25-50% of patients with Graves' disease developing signs and symptoms of TED.5
Teprotumumab binds to and inhibits the insulin-like growth factor-1 receptor (IGF-1R), a receptor involved in cellular signaling pathways associated with the development and progression of TED. By inhibiting IGF-1R signaling, teprotumumab helps reduce the inflammatory and tissue-remodeling processes associated with the disease. Tepezza® is administered by intravenous infusion and is a registered trademark of Amgen Inc.
References
[1] Polivy® (polatuzumab vedotin-piiq) U.S. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761121s008lbl.pdf [Last accessed October 2026].
[2] Wang, S. S. (2023) Epidemiology and Etiology of Diffuse Large B-Cell Lymphoma (DLBCL). Semin. Hematol. 60, 255–266.
[3] International Agency for Research on Cancer. Global Cancer Observatory: Non-Hodgkin Lymphoma Fact Sheet, GLOBOCAN 2024. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf [Last accessed October 2026]
[4] Tepezza® (teprotumumab-trbw) U.S. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s012lbl.pdf [Last accessed October 2026].
[5] Moledina, M., Damato, E. M. & Lee, V. (2024) The changing landscape of thyroid eye disease: current clinical advances and future outlook. Eye 38, 1425-37.
About Fresenius
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) is a global healthcare company headquartered in Bad Homburg vor der Höhe, Germany. In the full-year 2025, Fresenius generated €22.6 billion (excluding special items) in annual revenue. Fresenius employs more than 178,000 people. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in the separately listed Fresenius Medical Care AG.
With around 140 hospitals, 330 outpatient facilities and 300 occupational risk prevention centres, 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 fresenius.com and follow Fresenius Investor Relations on LinkedIn.
About Fresenius Medical Care
Fresenius Medical Care AG is an independent, separately listed company (XETR: FME; NYSE: FMS), in which Fresenius SE & Co. KGaA holds a financial investment of approximately 25%; Fresenius Medical Care's results are not consolidated in the Fresenius Group's revenue and earnings.
Forward-Looking Statements
This release contains forward-looking statements that are subject to various risks and uncertainties including statements regarding the potential number of biosimilar candidates developed under the agreement with WuXi Biologics, the resulting pipeline size (including references to "up to 66" molecules), the timing and scope of any transfer of manufacturing to the mAbxience network, and Fresenius' growth prospects beyond 2030. Whether, when and how many candidates are developed under the agreement remains subject to Fresenius' future exercise of options on a candidate-by-candidate basis, and no assurance can be given that any, or all, of the identified candidates will be developed or will reach the market. 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.
Correspondence Address
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Sara Hennicken, Dr. Marc-Alexander Mahl, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
Securities Information
Fresenius SE & Co. KGaA is listed on the Frankfurt Stock Exchange and is a member of the DAX 40 index. The shares are traded on Xetra, the electronic trading venue of Deutsche Börse, under the ticker FRE.
ISIN: DE000FRE5EN2 ● German Securities Code: FRE5EN
American Depository Receipts
Fresenius SE & Co. KGaA maintains a sponsored Level I American Depositary Receipt programme, traded over the counter in the United States on the OTC Markets platform under the ticker FSNUY, at a ratio of four American Depositary Receipts to one ordinary share. Depositary bank: J.P. Morgan Chase Bank N.A.
ISIN: US35804M1053 ● CUSIP: 35804M105
Contacts
For Media contacts, click here, and to contact Investor Relations, click here.
- Acquisition of the remaining 45% stake in mAbxience establishes a wholly owned, vertically integrated biopharma business covering the full value chain from research through commercialization
- Full ownership enhances control over future investments, manufacturing capacity, and decision-making; strengthening Fresenius' competitive position in the fast-growing biosimilars market of more than €180 billion by 2035
- Transaction supports the #FutureFresenius strategy by increasing exposure to a scalable, high-growth biopharma platform, and enabling full participation in future value creation
- The acquisition is expected to be immediately accretive to Group core earnings per share from completion
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) today announced that it has acquired the remaining 45% of mAbxience Holding S.L. (mAbxience) from Insud Pharma S.L. and Invim Corporativo, S.L. for a total consideration of up to €750 million including a contingent payment of €50 million upon site-approvals. The transaction was signed and completed on 30 September 2026 with no regulatory approvals required.
Fresenius acquired a 55% majority stake in mAbxience in August 2022 and has controlled and consolidated the business since then. Full ownership completes that structure: the biosimilars platform is now wholly owned within Fresenius Kabi’s Biopharma business, which covers the full value chain from research through to commercialization.
The acquisition builds on a successful partnership that has already delivered important development, manufacturing, technology-transfer, and regulatory milestones. Taking full ownership gives Fresenius the entire economic benefit of the platform and greater strategic flexibility to invest in manufacturing capacity, select future biosimilar opportunities, and pursue licensing partnerships at a time when a large wave of biologics is losing exclusivity. This fast-growing market is expected to grow approximately six times by 2035 to more than €180 billion. Bringing the organizations together under full ownership creates a stronger platform to enhance quality, supply resilience, and operational freedom, while supporting future innovation, and broader patient access to high-quality biosimilars. The transaction is consistent with the capital allocation priorities set out under #FutureFresenius.
Michael Sen, Chief Executive Officer of Fresenius, said: “Completing the acquisition of mAbxience marks the next milestone in building a leading, vertically integrated biopharma business at scale. When we first invested in mAbxience four years ago, the market opportunity was promising but still evolving. Our initial majority stake gave us access to a highly competitive platform while managing risk. Since then, the market has developed strongly, mAbxience has delivered, and Fresenius now has the financial strength to take this next step. Full ownership gives us complete control over cost, capacity and launch timing, and full economic benefit, as the next wave of biologics loses exclusivity. For patients, that means dependable access to high-quality biosimilars; for shareholders, it is a disciplined investment in a business we know well.”
Jurgen Van Broeck, Chief Executive Officer of mAbxience, said: “mAbxience was founded to serve patients, while proving that world-class biologics could be developed and manufactured at a cost the world could afford. Since 2022, our partnership with Fresenius has demonstrated the strength of combining our people, expertise, and capabilities. I would also like to recognize and thank Insud Pharma for its support and commitment over the past decade. The success of mAbxience today is built on the vision, dedication and hard work of many people who have contributed to this journey from the very beginning. Full ownership is the natural next step and creates an even stronger platform for innovation, growth, and long-term impact for patients, customers, and partners. As we begin this next chapter together, we will continue to build on the entrepreneurial spirit, scientific expertise, and commitment to patients that have driven mAbxience’s success.”
mAbxience is a leading global biopharmaceutical company that operates three multi-product state-of-the-art drug substance facilities in Spain and Latin America and employs over 1,300 people. mAbxience develops and manufactures biosimilar monoclonal antibodies and provides contract development and manufacturing services to partners. In 2025 mAbxience generated more than €320 million in revenue and contributed earnings before interest, taxes, depreciation, and amortization (EBITDA) margin that was accretive to the overall Fresenius Kabi margin. Its portfolio comprises four products on the market and eight candidates in development. Together with Fresenius Kabi’s development, regulatory, and commercial capabilities it covers the full value chain from laboratory to patient.
Jurgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business, reporting to Dr. Sang-Jin Pak, President Biopharma at Fresenius.
Full ownership positions the platform for further scale, including pipeline expansion opportunities, within Fresenius’ unchanged financial framework.
Financial Considerations
- Consideration: Up to €750 million in cash, including a contingent payment of €50 million upon site-approvals.
- Funding: Available liquidity and operating cash flow. No new financing was required.
- Balance sheet: The consideration settles the put option liability over the 45% non-controlling interest recognized in the Group’s consolidated balance sheet. Following the transaction, net debt to EBITDA is expected to increase by approximately 20 basis points, while leverage for the full year is expected to be towards the lower end of the self-imposed target corridor of 2.5x to 3.0x.
- Accounting: Under International Financial Reporting Standards, the acquisition of a non-controlling interest is an equity transaction; no goodwill arises. A 45% non-controlling interest has been presented to date: The transaction is expected to be immediately accretive to Group core earnings per share.
- Returns: The investment is expected to further improve the return on invested capital (ROIC) already above Fresenius’ cost of capital after the integration, in line with the Group’s capital allocation criteria.
- Credit ratings: Fresenius is rated BBB (outlook positive) by S&P, Baa3 (outlook stable) by Moody’s and BBB- (outlook positive) by Fitch. A strong balance sheet and continued deleveraging remain priorities.
Guidance: No change to full-year 2026 guidance or to the 2030 Biopharma ambition of approximately doubling revenue compared with 2025 at an EBIT margin of around 20%.
Related Publications
The 31 March 2022 announcement of Fresenius Kabi’s acquisition of a 55% majority stake in mAbxience is available here, and the 1 August 2022 completion announcement here. The Biopharma ‘Meet the Management’ presentation of 15 December 2025 is available here.
About mAbxience
mAbxience is a Spanish-based company specializing in the development, production and commercialization of biopharmaceuticals. mAbxience is a wholly owned company of Fresenius SE & Co. KGaA and part of Fresenius Kabi's Biopharma business.
With over fifteen years of expertise, mAbxience's mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance quality of life by ensuring universal access to high-caliber medicines. With four approved products and a robust pipeline in development, mAbxience has established a B2B presence in over 100 markets. Alongside this, the company has formed a network with more than 40 partners and built a dedicated team of over 1,300 professionals. Its three multiproduct facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization (CDMO) services, utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions.
For more information, visit www.mabxience.com or connect with mAbxience on LinkedIn.
About Fresenius
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) is a global healthcare company headquartered in Bad Homburg vor der Höhe, Germany. In the full-year 2025, Fresenius generated €22.6 billion (excluding special items) in annual revenue. Fresenius employs more than 178,000 people. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in the separately listed Fresenius Medical Care AG. With around 140 hospitals, 330 outpatient facilities and 300 occupational risk prevention centres, 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 fresenius.com and follow Fresenius Investor Relations on LinkedIn.
About Fresenius Medical Care
Fresenius Medical Care AG is an independent, separately listed company (XETR: FME; NYSE: FMS), in which Fresenius SE & Co. KGaA holds a financial investment of approximately 25%; Fresenius Medical Care's results are not consolidated in the Fresenius Group's revenue and earnings.
Forward-Looking Statements
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.
Correspondence Address
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
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
Securities Information
Fresenius SE & Co. KGaA is listed on the Frankfurt Stock Exchange and is a member of the DAX 40 index. The shares are traded on Xetra, the electronic trading venue of Deutsche Börse, under the ticker FRE.
ISIN: DE000FRE5EN2 ● German Securities Code: FRE5EN
American Depository Receipts
Fresenius SE & Co. KGaA maintains a sponsored Level I American Depositary Receipt programme, traded over the counter in the United States on the OTC Markets platform under the ticker FSNUY, at a ratio of four American Depositary Receipts to one ordinary share. Depositary bank: J.P. Morgan Chase Bank N.A.
ISIN: US35804M1053 ● CUSIP: 35804M105
Contacts
For Media contacts, click here, and to contact Investor Relations, click here.
- Opening of new I.V. product lines in Kutno, Poland and Isola della Scala, Italy
- Combined investments of €54 million; more than €1 billion invested in European manufacturing over the past five years
- Fresenius further advances local-for-local approach and commitment to European patient care
Bad Homburg, Germany, September 25, 2026 – Fresenius is strengthening its European manufacturing network with new and expanded production capabilities for intravenous (IV) fluids in Poland and Italy. This week, the company opened a new IV fluids production line in Kutno, Poland, and expanded its manufacturing and warehouse infrastructure in Isola della Scala, Italy. Both sites play an important role in supplying European healthcare systems with essential medicines, helping ensure access for hospitals and patients across the region. Together representing investments of €54 million, the projects increase local production capacity, reinforce healthcare supply chains, and strengthen the availability of essential healthcare products across Europe.
Over the past five years, Fresenius has invested more than €1 billion in European production to enhance resilience and support healthcare systems. As a global healthcare company, Fresenius manufactures many of its products close to the patients it serves. The company operates around 20 manufacturing facilities and several research and development centers across Europe.
Healthcare systems face growing demand, increasing complexity, and rising expectations for reliable access. Through the continuous expansion and modernization of its manufacturing network, Fresenius is helping improve the availability of critical medicines, clinical nutrition products, and medical technologies for patients.
"Europe needs strong healthcare systems supported by resilient local manufacturing. With our investments in Poland and Italy, we are bringing essential production closer to patients and advancing our local-for-local approach, while at the same time strengthening security of supply. Healthcare is part of Europe’s security architecture, and resilient value chains are essential for greater sovereignty. This is #FutureFresenius in action: focused investments that create value for patients, customers and our businesses."
Dr. Marc-Alexander Mahl, President Pharma, Medical Nutrition & Sustainability
The projects also reflect the company’s disciplined approach to advancing its core businesses and growth platforms during the Rejuvenate phase of #FutureFresenius, Fresenius’ transformation and growth strategy. By directing capital toward manufacturing expansion, innovation, and operational excellence, Fresenius is enhancing its long-term competitiveness.
The projects complement Fresenius’ broader European investment plan, including a €400 million financing agreement signed with the European Investment Bank (EIB) in 2025 to support research and development activities as well as manufacturing expansion within the European Union.
As part of #FutureFresenius, the company will continue investing in the long-term growth and competitiveness of its businesses across (Bio)Pharma, Nutrition, and MedTech, helping improve supply chain security and access to essential medicines and healthcare products for patients around the world.
About Fresenius
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) is a global healthcare company headquartered in Bad Homburg vor der Höhe, Germany. In the full-year 2025, Fresenius generated €22.6 billion (excluding special items) in annual revenue. Fresenius employs more than 178,000 people. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in the separately listed Fresenius Medical Care AG. With around 140 hospitals, 330 outpatient facilities and 300 occupational risk prevention centres, 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 fresenius.com and follow Fresenius Investor Relations on LinkedIn.
About Fresenius Medical Care
Fresenius Medical Care AG is an independent, separately listed company (XETR: FME; NYSE: FMS), in which Fresenius SE & Co. KGaA holds a financial investment of approximately 25%; Fresenius Medical Care's results are not consolidated in the Fresenius Group's revenue and earnings.
Forward-Looking Statements
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.
Correspondence Address
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
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
Securities Information
Fresenius SE & Co. KGaA is listed on the Frankfurt Stock Exchange and is a member of the DAX 40 index. The shares are traded on Xetra, the electronic trading venue of Deutsche Börse, under the ticker FRE.
ISIN: DE000FRE5EN2 ● German Securities Code: FRE5EN
American Depository Receipts
Fresenius SE & Co. KGaA maintains a sponsored Level I American Depositary Receipt programme, traded over the counter in the United States on the OTC Markets platform under the ticker FSNUY, at a ratio of four American Depositary Receipts to one ordinary share. Depositary bank: J.P. Morgan Chase Bank N.A.
ISIN: US35804M1053 ● CUSIP: 35804M105
Contacts
For Media contacts, click here, and to contact Investor Relations, click here.
- Opening of new I.V. product lines in Kutno, Poland and Isola della Scala, Italy
- Combined investments of €54 million; more than €1 billion invested in European manufacturing over the past five years
- Fresenius further advances local-for-local approach and commitment to European patient care
Fresenius is strengthening its European manufacturing network with new and expanded production capabilities for intravenous (IV) fluids in Poland and Italy. This week, the company opened a new IV fluids production line in Kutno, Poland, and expanded its manufacturing and warehouse infrastructure in Isola della Scala, Italy. Both sites play an important role in supplying European healthcare systems with essential medicines, helping ensure access for hospitals and patients across the region. Together representing investments of €54 million, the projects increase local production capacity, reinforce healthcare supply chains, and strengthen the availability of essential healthcare products across Europe.
Over the past five years, Fresenius has invested more than €1 billion in European production to enhance resilience and support healthcare systems. As a global healthcare company, Fresenius manufactures many of its products close to the patients it serves. The company operates around 20 manufacturing facilities and several research and development centers across Europe.
Healthcare systems face growing demand, increasing complexity, and rising expectations for reliable access. Through the continuous expansion and modernization of its manufacturing network, Fresenius is helping improve the availability of critical medicines, clinical nutrition products, and medical technologies for patients.
"Europe needs strong healthcare systems supported by resilient local manufacturing. With our investments in Poland and Italy, we are bringing essential production closer to patients and advancing our local-for-local approach, while at the same time strengthening security of supply. Healthcare is part of Europe’s security architecture, and resilient value chains are essential for greater sovereignty. This is #FutureFresenius in action: focused investments that create value for patients, customers and our businesses."
Dr. Marc-Alexander Mahl, President Pharma, Medical Nutrition & Sustainability
The projects also reflect the company’s disciplined approach to advancing its core businesses and growth platforms during the Rejuvenate phase of #FutureFresenius, Fresenius’ transformation and growth strategy. By directing capital toward manufacturing expansion, innovation, and operational excellence, Fresenius is enhancing its long-term competitiveness.
The projects complement Fresenius’ broader European investment plan, including a €400 million financing agreement signed with the European Investment Bank (EIB) in 2025 to support research and development activities as well as manufacturing expansion within the European Union.
As part of #FutureFresenius, the company will continue investing in the long-term growth and competitiveness of its businesses across (Bio)Pharma, Nutrition, and MedTech, helping improve supply chain security and access to essential medicines and healthcare products for patients around the world.
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
NutriChef launches in several European markets and combines real food ingredients1 with the consistency and nutritional completeness of medical nutrition
- The launch of NutriChef, the fifth product launch within Fresenius’ Medical Nutrition portfolio in 2026, reflects the company’s commitment to patient-centered innovation-led growth and further strengthens its portfolio in nutritional care
- NutriChef expands Fresenius’ enteral nutrition offering with a real-food-based concept designed around the needs of patients, caregivers, and healthcare professionals
- Medical Nutrition is an attractive healthcare market supported by aging populations, increased demand for homecare, and growing awareness of the role of nutrition in patient care
Fresenius announced today the launch of NutriChef, a new enteral nutrition option that combines real food ingredients1 such as fruit and vegetables while maintaining the nutritional completeness required for medical nutrition, in Germany, Switzerland, Norway, Netherlands, Denmark, and Sweden.
The product is designed to bridge the gap between conventional formula-based tube feeding and the familiarity associated with real meals and home-prepared foods. Available in three nutritionally complete, meal-inspired varieties2, they contain ingredients derived from 21 different plants and more than 75 percent real food ingredients, including water and oils1. The product provides high energy and protein as well as a blend of soluble and insoluble fibers.
“For many patients, the challenge is not only getting the nutrition they need. It is adapting to a new reality,” said Sebastien Guery, Executive Vice President Business Unit Medical Nutrition. “NutriChef responds to that need by combining familiar foods into enteral feeding with the safety, consistency and nutritional standards required in medical care. It is also a testament to the innovation-led growth of Fresenius, reflecting our ability to translate evolving patient needs into differentiated innovations and meaningful portfolio expansion.”
Developed for patients who require enteral nutrition, the new offering combines familiar food-based ingredients with the reliability and quality standards expected from medical nutrition. It offers patients, caregivers, and healthcare professionals an additional option that brings familiar food concepts into nutritional care.
As populations age and more care shifts beyond the hospital into outpatient and homecare settings, nutritional support is becoming increasingly important across healthcare systems. Fresenius continues to see strong long-term demand in Medical Nutrition, supported by demographic trends, growing awareness of disease-related malnutrition, and the need for solutions that fit into patients’ daily lives.
As the fifth addition to Fresenius’ Medical Nutrition portfolio introduced in 2026, NutriChef underscores the company’s continued investment in nutritional care across enteral and parenteral nutrition, the company continues to expand access to high-quality medical nutrition while addressing practical challenges faced by patients, caregivers, and healthcare professionals. As part of #FutureFresenius, the company continues to strengthen its portfolio with differentiated solutions that address evolving patient needs.
NutriChef is a food for special medical purposes for the dietary management of disease-related malnutrition, to be used under medical supervision. Product availability may vary by market.
NutriChef is essentially designed as an adult medical nutrition product, with limited, controlled use in:
- children >3 years (restricted)
- adolescents (possible full use only with medical supervision)
References
1 Fresenius Kabi. NutriChef Ingredient List and Product Specification. Fresenius Kabi; 2026.
2 Fresenius Kabi Market Research; Real Food & Tube Feeding Insights Study, 2022.
About Fresenius
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) is a global healthcare company headquartered in Bad Homburg vor der Höhe, Germany. In the full-year 2025, Fresenius generated €22.6 billion (excluding special items) in annual revenue. Fresenius employs more than 178,000 people. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in the separately listed Fresenius Medical Care AG. With around 140 hospitals, 330 outpatient facilities and 300 occupational risk prevention centres, 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 fresenius.com and follow Fresenius Investor Relations on LinkedIn.
About Fresenius Medical Care
Fresenius Medical Care AG is an independent, separately listed company (XETR: FME; NYSE: FMS), in which Fresenius SE & Co. KGaA holds a financial investment of approximately 25%; Fresenius Medical Care's results are not consolidated in the Fresenius Group's revenue and earnings.
Forward-Looking Statements
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.
Correspondence Address
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
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
Securities Information
Fresenius SE & Co. KGaA is listed on the Frankfurt Stock Exchange and is a member of the DAX 40 index. The shares are traded on Xetra, the electronic trading venue of Deutsche Börse, under the ticker FRE.
ISIN: DE000FRE5EN2 ● German Securities Code: FRE5EN
American Depository Receipts
Fresenius SE & Co. KGaA maintains a sponsored Level I American Depositary Receipt programme, traded over the counter in the United States on the OTC Markets platform under the ticker FSNUY, at a ratio of four American Depositary Receipts to one ordinary share. Depositary bank: J.P. Morgan Chase Bank N.A.
ISIN: US35804M1053 ● CUSIP: 35804M105
Contacts
For Media contacts, click here, and to contact Investor Relations, click here.
NutriChef launches in several European markets and combines real food ingredients1 with the consistency and nutritional completeness of medical nutrition
- The launch of NutriChef, the fifth product launch within Fresenius’ Medical Nutrition portfolio in 2026, reflects the company’s commitment to patient-centered innovation-led growth and further strengthens its portfolio in nutritional care
- NutriChef expands Fresenius’ enteral nutrition offering with a real-food-based concept designed around the needs of patients, caregivers, and healthcare professionals
- Medical Nutrition is an attractive healthcare market supported by aging populations, increased demand for homecare, and growing awareness of the role of nutrition in patient care
Fresenius announced today the launch of NutriChef, a new enteral nutrition option that combines real food ingredients1 such as fruit and vegetables while maintaining the nutritional completeness required for medical nutrition, in Germany, Switzerland, Norway, Netherlands, Denmark, and Sweden.
The product is designed to bridge the gap between conventional formula-based tube feeding and the familiarity associated with real meals and home-prepared foods. Available in three nutritionally complete, meal-inspired varieties2, they contain ingredients derived from 21 different plants and more than 75 percent real food ingredients, including water and oils1. The product provides high energy and protein as well as a blend of soluble and insoluble fibers.
“For many patients, the challenge is not only getting the nutrition they need. It is adapting to a new reality,” said Sebastien Guery, Executive Vice President Business Unit Medical Nutrition. “NutriChef responds to that need by combining familiar foods into enteral feeding with the safety, consistency and nutritional standards required in medical care. It is also a testament to the innovation-led growth of Fresenius, reflecting our ability to translate evolving patient needs into differentiated innovations and meaningful portfolio expansion.”
Developed for patients who require enteral nutrition, the new offering combines familiar food-based ingredients with the reliability and quality standards expected from medical nutrition. It offers patients, caregivers, and healthcare professionals an additional option that brings familiar food concepts into nutritional care.
As populations age and more care shifts beyond the hospital into outpatient and homecare settings, nutritional support is becoming increasingly important across healthcare systems. Fresenius continues to see strong long-term demand in Medical Nutrition, supported by demographic trends, growing awareness of disease-related malnutrition, and the need for solutions that fit into patients’ daily lives.
As the fifth addition to Fresenius’ Medical Nutrition portfolio introduced in 2026, NutriChef underscores the company’s continued investment in nutritional care across enteral and parenteral nutrition, the company continues to expand access to high-quality medical nutrition while addressing practical challenges faced by patients, caregivers, and healthcare professionals. As part of #FutureFresenius, the company continues to strengthen its portfolio with differentiated solutions that address evolving patient needs.
NutriChef is a food for special medical purposes for the dietary management of disease-related malnutrition, to be used under medical supervision. Product availability may vary by market.
NutriChef is essentially designed as an adult medical nutrition product, with limited, controlled use in:
- children >3 years (restricted)
- adolescents (possible full use only with medical supervision)
References
1 Fresenius Kabi. NutriChef Ingredient List and Product Specification. Fresenius Kabi; 2026.
2 Fresenius Kabi Market Research; Real Food & Tube Feeding Insights Study, 2022.
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.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL), a biosimilar to Rituxan®* (rituximab).1
Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the biosimilar in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories.
"FDA approval of rituximab biosimilar represents an important milestone for Fresenius Kabi, further strengthening our U.S. biosimilars footprint with a well-established molecule that strategically complements our oncology and immunology portfolios. This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes. It is widely used in the treatment of adults with several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.2
The FDA approval is supported by a totality of the evidence approach, including analytical, non-clinical, and clinical data demonstrating that the product is highly similar to and has no clinically meaningful differences from the reference product, Rituxan®, consistent with U.S. FDA requirements for biosimilar approval.
Biopharma is a core pillar of Fresenius' #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business covering the entire value chain, from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high-quality, affordable biologic therapies. The approval of the rituximab biosimilar represents another important step in strengthening Fresenius Kabi's growing biosimilars portfolio.
About Rituximab
Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.
Rituximab is approved for the treatment of adults with several hematologic malignancies and autoimmune diseases in the United States, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).2
The rituximab biosimilar was developed and manufactured by Dr. Reddy's Laboratories. Fresenius Kabi holds exclusive commercialization rights in the United States.
The biosimilar development program was designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, pharmacokinetic, and clinical studies, in line with FDA requirements for biosimilar approval.
About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company's broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home, reaching 450 million patients each year.
Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology; and intravenous generic drugs and fluids that advance essential patient care worldwide.
For more information, please visit www.fresenius-kabi.com.
About Fresenius
Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and numerous outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects.
For more information visit the Company’s website at www.fresenius.com.
Visit our media center: www.fresenius.com/media-center.
References
1 U.S. Food and Drug Administration approval information for rituximab biosimilar developed by Dr. Reddy's Laboratories.
2 Rituxan® (rituximab) U.S. Prescribing Information. Rituxan® is a registered trademark of Genentech, Inc.
Fresenius (XFRA: FRE, OTC: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually.
With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.com and follow Fresenius on LinkedIn.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch
Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration.
The applications were submitted by Polpharma Biologics S.A.1, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.
“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”
PB016, in-licensed from Polpharma Biologics S.A.1, is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. 2,3 It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies.
The submissions for the intravenous presentation are supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval.
Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high quality, affordable biologic therapies. The FDA and EMA review acceptances represent the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position.
About vedolizumab
Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.4
It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, chronic inflammatory diseases that can significantly impact patients’ quality of life.
Vedolizumab is administered by intravenous infusion.
PB016 is being developed and manufactured by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval.
The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non‑clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).5
About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.
Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide.
For more information, please visit www.fresenius-kabi.com.
References
1 Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026]
2 Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197–1205.
3 Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology, 16, 1-16.
4 Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437–44.
5 ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* (UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* | ClinicalTrials.gov [Last accessed: June 2026]
* Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company.
Fresenius (XFRA: FRE, OTCQX: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27 million patients annually.
With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.
For more information, visit www.fresenius.comand follow Fresenius Investor Relations on LinkedIn.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration.
The applications were submitted by Polpharma Biologics, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.
“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”
PB016, in-licensed from Polpharma Biologics S.A1, is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The biosimilar candidate is being developed and manufactured by Polpharma, with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals.
Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. 2,3 It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies.
The BLA submission for the intravenous presentation is supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval.
Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high quality, affordable biologic therapies. The FDA’s acceptance of the BLA represents the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position.
About vedolizumab
Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.4
It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, chronic inflammatory diseases that can significantly impact patients’ quality of life.
Vedolizumab is administered by intravenous infusion.
PB016 is being developed by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval.
The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non‑clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).5
About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.
Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide.
For more information, please visit www.fresenius-kabi.com.
References
1 Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026]
2 Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197–1205.
3 Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology, 16, 1-16.
4 Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437–44.
5 ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* (UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®* | ClinicalTrials.gov [Last accessed: June 2026]
* Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Dr. Michael Moser, Dr. Christian Pawlu
Chairman of the Supervisory Board: Wolfgang Kirsch