- 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.
For further details see:
FDA approves Fresenius Kabi's cancer drug Stimufend, a biosimilar to Amgen's Neulasta