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)

Grandbrothers

  • 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.

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