By IDSE News Staff
The FDA approved pegfilgrastim-fpgk (Stimufend, Fresenius Kabi) a biosimilar of Neulasta (Amgen), for patients with non-myeloid malignancies receiving myelosuppressive anticancer 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.
Pegfilgrastim-fpgk is Fresenius Kabi’s first U.S.-approved therapy in its