Fresenius continues to reduce complexity and increase efficiency in its global network. In line with #FutureFresenius, the company announces the divestment of Fresenius Kabi’s Calea homecare business in Canada. This includes the divestment of four sites across the country, including the head office in Mississauga, Ontario, as well as the offices in Hamilton, Ontario, Burnaby, British Columbia, and Calgary, Alberta.
The company has sold the Calea business in Canada to Capital Health Partners (CHP), a Canadian-owned and operated healthcare company committed to advancing the delivery of medical supplies, equipment, pharmaceuticals, and pharmacy services across Canada. Fresenius Kabi continues to supply the Canadian market with its broad portfolio of products and thereby remains a close partner to health care delivery in Canada.
Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities.
PB016 is a biosimilar candidate to Entyvio®*, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease.
“Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.”
This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy.
*Entyvio® is a registered trademark of Takeda.
Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe.
The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone.
This milestone marks a significant advancement in Fresenius Kabi’s mission to expand access to high-quality biosimilar therapies. It also reinforces the business’ commitment to strengthening its Biopharma platform, a key pillar of the #FutureFresenius strategy.
*Conexxence and *Bomyntra are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.
Fresenius announced today that its Operating Company Fresenius Kabi has introduced two new biosimilars in the U.S., Conexxence®(1) (denosumab-bnht) and Bomyntra®(2) (denosumab-bnht).
These denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia®(3) (denosumab) and Xgeva®(4) (denosumab), respectively. The biological medicines are used for the treatment of osteoporosis and other bone-related conditions.
This milestone represents Fresenius’ fifth and sixth biosimilars available in the U.S. It is a showcase of the company’s efforts to drive patient access to high-quality biological medicines. Earlier this year, Fresenius announced a global settlement with Amgen concerning its denosumab biosimilars. The company thereby continues the growth path of its BioPharma platform in line with #FutureFresenius.
Conexxence®(1) and Bomyntra®(2) are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries. Prolia®(3) and Xgeva®(4) are registered trademarks of Amgen Inc.
Read the full press release here.
Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for its denosumab biosimilar candidates for the treatment of osteoporosis and other bone-related conditions.
The biosimilars are recommended for approval for all indications of the reference products 1Prolia® (denosumab) and 2Xgeva® (denosumab) from AMGEN.
The CHMP positive opinion marks an important step in Fresenius Kabi's efforts to enhance patient access to biosimilar products and expand its capabilities and portfolio in biosimilars development. Developing the company's Biopharma platform is a key element of #FutureFresenius.
1Prolia® and 2Xgeva® are registered trademarks of Amgen Inc.
Fresenius today announced that its operating company, Fresenius Kabi, is now offering Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States. Following the introduction of the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers in December 2024, the product launch expands Fresenius’ offerings of Epinephrine Injection.
Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. More than 70% of the pharmaceuticals that Fresenius Kabi sells to U.S. customers are formulated, filled and packaged in the U.S.
The Fresenius healthcare group and the Else Kröner-Fresenius Foundation are today paying tribute to the impressive legacy of Else Kröner, née Fernau (1925–1988), with a commemorative event. Around 170 guests representing science, politics, business, and society have been invited to the Städel Museum in Frankfurt. Among them are Nobel Prize winner for Medicine, Prof. Dr. Craig Mello; the Hessian Minister for Science and Research, Art and Culture, Timon Gremmels; the Lord Mayor of Bad Homburg v. d. Höhe, Alexander Hetjes; and the Chairman of Fresenius Supervisory Board, Wolfgang Kirsch.
Else Kröner was born in Frankfurt am Main exactly 100 years ago, on May 15, 1925. As long-time Managing Director and later Chairwoman of the Supervisory Board, she laid the foundations for Fresenius’ success as a leading global healthcare group. The Else Kröner-Fresenius Foundation (EKFS), which she established in 1983, is today Germany’s largest foundation dedicated to the advancement of medicine.
“Else Kröner was one of Germany’s most successful female entrepreneurs. She shaped the global healthcare company that Fresenius is today and in doing so, she wrote business history. On the occasion of her 100th birthday, we would like to pay tribute to her remarkable legacy. Throughout her life, Else Kröner demonstrated great foresight and entrepreneurial courage. These qualities are today needed more than ever to secure Germany’s growth and prosperity as a business location. My 176,000 colleagues at Fresenius and I have taken over the task of building on the legacy she left behind. With #FutureFresenius, we are doing precisely this so that we can continue to fulfil our mission: To save and improve human lives. We are Committed to Life,” says Fresenius CEO Michael Sen.
“Else Kröner was both an outstanding entrepreneur and a passionate advocate of medical research and education. Her unwavering commitment and vision have made the Else Kröner-Fresenius Foundation what it is today – a driving force in the advancement of science and health. Since its founding, the Else Kröner-Fresenius Foundation has contributed more than 700 million euros to around 2,800 medical, scientific, and humanitarian projects. Her extraordinary lifework is a lasting source of inspiration for us all,” says Dr. Dieter Schenk, Chairman of the Board of the Else Kröner-Fresenius Foundation.
From pharmacy to global enterprise that sets industry standards
When Else Kröner, the foster daughter of company founder Dr. Eduard Fresenius, officially took over management of the Hirsch Pharmacy in Frankfurt and “Dr. Eduard Fresenius chemisch-pharmazeutische Industrie KG” in 1952, the family business only had around 40 employees. The qualified pharmacist used her entrepreneurial vision to transform the company into a global healthcare group. She did this by expanding the product range, developing dialysis machines in- house, accessing international markets, and making targeted company acquisitions.Under her leadership, and that of her husband Dr. Hans Kröner, Fresenius researchers developed important medical innovations for the European market. These include infusion solutions in plastic bottles, which are still the industry standard today, and the first liquid food for diabetics.
Else Kröner’s legacy
Else Kröner’s achievements and commitment still shape Fresenius today. The company stands for access to affordable and innovative medical products and clinical care of the highest quality. Every year, Fresenius treats around 26 million patients and improves the lives of around 450 million people worldwide. With the current Rejuvenate phase of its #FutureFresenius program, the company is consistently focusing on the healthcare of tomorrow. Else Kröner’s values are reflected in the Fresenius Principles and are lived every day by employees in more than 80 countries.
Else Kröner Fresenius Prize for Medical Research
The Else Kröner-Fresenius Foundation will confer the Else Kröner Fresenius Prize for Medical Research during today’s ceremony. Endowed with 2.5 million euros, it will go to US researcher Prof. Dr. Anastasia Khvorova for her pioneering work in the field of RNA-based therapies. The foundation will also present a new biographical film about the life and work of Else Kröner.
For more information on Else Kröner, see www.fresenius.com/100YearsOfElseKroener
Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2024 fiscal year, Fresenius generated €21.5 billion in annual revenue. Fresenius currently counts over 176,000 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 countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 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.
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Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively.
Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later end of November 2025 subject to regulatory approval.
The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.
*Prolia® and Xgeva®* are registered trademarks of Amgen Inc.
**Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries.
Read the full press release here.
Please click to see full Prescribing Information for Conexxence®.
Please click to see full Prescribing Information for Bomyntra®.
Fresenius announced today that its Operating Company Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab).
In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. In September 2024, U.S. FDA and EC approval for both subcutaneous and intravenous formulations was received. Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis in the U.S. Being Fresenius’ fourth biosimilar on the market, the company continues the growth path of its BioPharma platform in line with #FutureFresenius.
Fresenius, via its operating company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Adaptive Nomogram, an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System.
The Adaptive Nomogram enables an average 11.6% increase in plasma collection per donation while maintaining safe and effective operation. This enhanced capability will allow plasma centers to improve collection efficiency. Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies. The clearance received for the Adaptive Nomogram is another milestone in line with #FutureFresenius.