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mAbxience, a Fresenius Kabi majority-owned Group, today announced a strategic partnership with Abbott to commercialize several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets including Latin America, Southeast Asia, the Middle East, and Africa. The first molecules are expected to be launched in 2025. mAbxience will manufacture the biosimilars in its state-of-the art and Good Manufacturing Practices (GMP)-approved facilities in Spain and Argentina. Additionally, mAbxience will be responsible for driving the clinical milestones for some of the molecules still undergoing development. The biosimilars will be commercialized by Abbott. This strategic partnership strengthens mAbxience’s global presence and expands access to cutting-edge healthcare solutions in underserved regions.

The European Commission (EC) has approved Fresenius Kabi’s tocilizumab biosimilar Tyenne®*. It is the first tocilizumab biosimilar approved by the EC and Fresenius Kabi’s third approved biosimilar in Europe. This approval is another crucial milestone in the company’s Vision 2026 growth strategy. * Tyenne® (tocilizumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

The rate of change, a key parameter for determining the price increase for the reimbursement of hospital treatments in 2024 in Germany, has been set at 4.22%. Due to cost inflation, the rate of change will most likely mark the lower limit of the price increase for hospital treatments for 2024 in Germany. The change in hospital costs is the other parameter used in the annual determination of the reimbursement increase. The final DRG inflator should be determined at the latest by the end of the year.

Fresenius Kabi announced today it has signed an agreement with Virginia Oncology Associates (VOA) under which VOA will purchase the Ivenix Infusion System to deliver medications for its patients. VOA specializes in treating people with cancer and blood disorders. It is part of the national US Oncology network. Fresenius Kabi and VOA have agreed to work together to integrate the Ivenix Infusion System with VOA’s electronic medical record (EMR) system.

The rating agency Fitch today revised the outlook of Fresenius from negative to stable. The rating was affirmed at BBB-. The improved outlook is based on the consistent performance of the Operating Companies, a prudent capital allocation and progress on the group simplification, amongst others. The revised outlook is another strong testament of the successful execution of the strategy towards #FutureFresenius. Fresenius remains committed to its investment grade rating and its self-imposed leverage corridor of 3.0 to 3.5x net debt/EBITDA.

Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Gadobutrol Injection, a gadolinium-based contrast agent for used in MRIs.1 It is the latest addition to Fresenius Kabi’s new radiology portfolio that offers hospitals a range of cost-effective contrast agents. The second product, Plerixafor Injection, a hematopoietic stem cell mobilizer is the newest addition to the company’s large generic injectable oncology medicine portfolio. 1 Gadobutrol Injection Package Insert, January 2023

Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025. FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders. * Stelara® is a registered trademark of Johnson & Johnson

Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases. This achievement marks a significant milestone in Fresenius Kabi’s Vision 2026 growth strategy. For more information, please see the website of Fresenius Kabi.

Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. For more information, please see the website of Fresenius Kabi. *Prolia® is a registered trademark of Amgen Inc.

Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Ganirelix Acetate Injection, a generic fertility drug is part of the company’s expansion in women’s health. Ganirelix Acetate Injection is indicated for the inhibition of premature surges in luteinizing hormone, a chemical in the body that triggers reproductive processes such as ovulation. The second product is fentanyl citrate in a Simplist® ready-to-administer prefilled syringe presentation. The product is the only 100 mcg per 2 mL presentation available on the U.S. market in a manufacturer-prepared prefilled syringe.

Fresenius Kabi announced today the launch of its citrate-free biosimilar Idacio®* (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases, in the U.S. Idacio® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®** (adalimumab). Idacio® is Fresenius Kabi’s second biosimilar launched in the U.S. and another key milestone in the company’s Vision 2026 growth strategy to broaden its biopharma global reach.