Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions.
That the United States (U.S.) Food and Drug Administration (FDA) has approved its biosimilar, Stimufend® (pegfilgrastim-fpgk), 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 - fpgk) 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® (pegfilgrastim - fpgk) is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
For more information please visit,www.fresenius-kabi.com.
