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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.

Fresenius continues reducing complexity and optimizing utilization in the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi and EMS have signed an agreement to transfer the ownership of Fresenius Kabi's production site in Anápolis, Brazil, to EMS. The multinational pharmaceutical company has a strong presence in Latin America and will take over the generic injectables production plant, the development center, and the warehouse as well as full staff and will continue production. The transaction is subject to customary closing conditions, including merger approval.

Fresenius has completed the divestment of Vamed’s international project business to Worldwide Hospitals Group (WWH), that was announced in February 2025. The divestment is part of Fresenius’ structured exit from its Investment Company Vamed and enables Fresenius to further increase focus and management capacity on the ongoing progress of its core businesses Fresenius Kabi and Fresenius Helios, in line with #FutureFresenius.

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®.