> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Fresenius Kabi Biosimilar
- URL: https://www.fdaweb.com/fda-approves-fresenius-kabi-biosimilar/
- Published: 2022-09-06T12:00:00.000Z
- Updated: 2026-09-14T17:58:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152677

FDA has approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company says the approval was 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.”