Fresenius Kabi gains U.S. approval of new cancer drug
LAKE ZURICH - Fresenius Kabi Thursday announced the immediate availability in the U.S. of Stimufend, a drug similar to Neulasta, for use in patients at risk for febrile neutropenia, a common side effect of many anti-cancer medications.
Stimufend is available in a single-dose, pre-filled syringe, the pharmaceutical company said.
"Fresenius Kabi is excited to launch Stimufend as it represents both our first biosimilar product in the U.S. and our long-term commitment to build a U.S. biosimilars business that supports patients, health care providers and payers," said Ali Ahmed, senior vice president, Biosimilars division at Fresenius Kabi USA.
Fresenius Kabi is a leading producer of injectable oncology medicines in the U.S., with more than 30 products used in more than 460 different chemotherapy regimens.
The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta, the company said.