Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (Pegfilgrastim)
Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved its 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 early next year and in an on-body injector following FDA approval.
Earlier this year, the company received the European Commission’s (EC) marketing authorization for Stimufend® and it intends to launch its pegfilgrastim biosimilar in a prefilled syringe in Europe in the fall.
“This is a strategic milestone for Fresenius Kabi in one of the most important and fast-growing markets for biopharmaceuticals,” said Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius. “The company consequently expands its presence and position in the highly attractive U.S. biosimilars marketplace in line with Vision 2026.”
Stimufend® is Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio, expanding its extensive Oncology portfolio to treat even more cancer patients in the U.S. The company’s pegfilgrastim biosimilar is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy.
Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board, said: “The FDA approval of our pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States. With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the U.S.”
The approval for Stimufend® (pegfilgrastim) is based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product. No clinically meaningful differences in safety and immunogenicity were observed.
About Stimufend, a pegfilgrastim biosimilar
Stimufend®, a pegfilgrastim biosimilar medicine of Neulasta®**, is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.***
Stimufend® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
* Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
** Neulasta® is a registered trademark of Amgen Inc.
*** It is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.
With its corporate philosophy of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.
Fresenius Kabi employs more than 41,000 people worldwide. In 2021, the company reported sales of more than €7.2 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.
For more information visit the company’s website at www.fresenius-kabi.com
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.
Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654