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 U.S. biosimilar 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.

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. *RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

Fresenius Kabi introduces a three-year plan in the US to add two-dimensional (2D) barcodes to its pharmaceutical portfolio of vials, syringes, IV solutions and parenteral nutrition products. The initiative will help streamline workflows at health care facilities by reducing error-prone manual data entry in medication management systems. Fresenius Kabi is the first pharmaceutical company in the US to commit to offering 2D barcodes on all drug product labels. The US project marks an important milestone within the global product marking initiative of Fresenius Kabi, focusing on offering scannable products to support customer and patient needs.

The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. *Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

Fresenius Kabi closed the majority stake acquisition of mAbxience Holding S.L. (“mAbxience”), a leading international biopharmaceutical company. The transaction was announced in March 2022. The acquisition significantly strengthens Fresenius Kabi’s footprint in the biopharmaceuticals space by broadening the product portfolio and expanding its production network with three state-of-the-art facilities for the production of biologic drug substance. This will enable Fresenius Kabi to cover the entire biopharmaceuticals value chain in the future and create flexible, competitive capacities for the production of the expanded biosimilars portfolio. The additional production capacities are expected to generate significant cost synergies with regard to the company's own biosimilars portfolio. Furthermore, the acquisition enables further expansion in the high-growth CDMO (Contract Development and Manufacturing Organization) market for biologics. The purchase price will be a combination of c. €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets. The contractual provisions also include a put / call option scheme regarding the sellers’ and future co-owners’ remaining shares in mAbxience (45%).

Thiotepa Injection, a cancer therapeutic, is now available from Fresenius Kabi in the United States. It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary. This is the newest addition to the company’s portfolio of generic IV oncology products - the largest such portfolio in the U.S.