FDA Approves Stimufend, Biosimilar for Neulasta

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.