FDA approves Fresenius Kabi's cancer drug Stimufend, a biosimilar to Amgen's Neulasta

Sep. 02, 2022 2:54 PM ETFresenius SE & Co. KGaA (FSNUF), FSNUY, AMGNBy: Anuron Mitra, SA News Editor

Headquarters of US Food and Drug Administration (FDA)


  • The U.S. Food and Drug Administration (FDA) on Friday approved Fresenius Kabi's (OTCPK:FSNUF) (OTCPK:FSNUY) Stimufend, a biosimilar to U.S. pharmaceutical major Amgen's (NASDAQ:AMGN) Neulasta drug.
  • Stimufend is a white blood cell growth factor indicated to decrease infection manifested by fever in patients with non-myeloid malignancies, or cancer that is not related to the bone-marrow, the FDA said in the prescribing information highlights for the drug.
  • Stimufend is a biosimilar to Amgen's (AMGN) Neulasta, which means that there are no clinically meaningful differences between the two treatments.
  • AMGN earlier in August reported total Neulasta sales of $310M for Q2, down 36% Y/Y.
  • Stimufend, like Neulasta, is also administered through injection.
  • AMGN stock -1.2% to $242.45 in afternoon trading.

Recommended For You


To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.