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.
The global healthcare company Fresenius is collaborating with other companies and academic institutions with the goals of accelerating the manufacturing of CAR-T cell therapy, making it more cost-effective, and improving patient access across Europe. Led by Fresenius, the newly launched EASYGEN (Easy workflow integration for gene therapy) consortium will focus on efforts to develop a modular, hospital-based platform capable of manufacturing personalized cell therapies in just a few days, rather than weeks. The project is a public-private partnership, with €8 million in funding provided by the EU through the Innovative Health Initiative (IHI). It leverages technology originally developed by the Cell and Gene Therapy team of Fresenius Kabi, part of Fresenius.
Read the full press release here.
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 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 internationally experienced and highly recognized communications expert Anke Schmidt has been appointed Head of Corporate Communications at Fresenius, effective June 1, 2025. She will succeed Dennis Hofmann, who headed the global communications function at Fresenius since September 2022 and has decided to leave the company on his own request to pursue new opportunities.
Anke Schmidt joins Fresenius from Beiersdorf, where she has served as Global Vice President Corporate Communications & Government Relations since 2020. Prior to that, she held various senior roles in Communications, Government Relations, and Human Resources at BASF over a period of 24 years, both in Germany and abroad.
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.
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 11.5% 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.