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%).