Fresenius Kabi has entered into a global license agreement to commercialize a Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG. The proposed biosimilar is currently in advanced clinical stage. FYB202 is a biosimilar candidate referencing Johnson & Johnson’s Stelara®*, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. Stelara is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The global license agreement gives Fresenius Kabi exclusive rights to commercialize the proposed Ustekinumab biosimilar product in key global markets. *Stelara® is a registered trademark of Johnson & Johnson

Fresenius Kabi expands its portfolio of critical care medicine by launching Lacosamide Injection, USP, a generic equivalent to VIMPAT® in the U.S. Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in the U.S. beginning today. * VIMPAT® is a registered trademark of UCB, Inc.

In this year's ranking, CDP has confirmed Fresenius' classification in the second-highest category B. Fresenius is thus once again one of the leading companies in the health care sector. Companies in categories A and B are characterized by transparency, coordinated climate protection measures and the implementation of corresponding best-practice approaches. CDP is one of the most renowned climate and environmental rankings in the capital market. More than 680 investors use the annual results to evaluate climate protection activities and climate-related risks and opportunities of the companies assessed.

Fresenius has been included again in the Dow Jones Sustainability Index (DJSI Europe). The DJSI Europe index represents the top 20 percent of companies based on S&P Global’s analysis of their economic, environmental, and social performance. Fresenius achieved improvements in many categories, the most significant ones in the areas of Occupational Health and Safety, Climate Strategy, as well as Risk and Crisis Management.

The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s biosimilar Idacio®, a citrate-free formulation of adalimumab. Idacio® (adalimumab) is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira®**. With Idacio Fresenius Kabi expands its U.S. biosimilars portfolio focused on immunology and oncology. It is the company’s second approved biosimilar in the U.S. launching from July 2023 in accordance with the relevant patent settlement agreement with Abbvie. * Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries **Humira® is a registered trademark of AbbVie, Inc.

Fresenius Kabi introduced Pralatrexate Injection, a drug for the treatment of relapsed or refractory peripheral T-cell lymphoma in the U.S. Fresenius Kabi Pralatrexate Injection is a generic of Folotyn® and is available to customers immediately. It is the newest addition to the company’s injectable oncology medicine portfolio, the largest in U.S. health care. *Folotyn® is a registered trademark of Acrotech Biopharma.

Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®*. This is the second contrast agent introduced by Fresenius Kabi in the U.S. this year. Contrast agents are used by radiologists to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi. *Dotarem® is a registered trademark of Guerbet.

The price increase for hospital services in Germany has been set at 3.45 % for 2023. As it is subject to negotiations at the state level as well as individual hospital discounts, the final price increase on the individual hospital level will, however, be lower.

The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval. This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio. * Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc.