Fresenius Kabi announced the immediate availability in the U.S. of Stimufend, the company’s biosimilar 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 that delivers 6mg/0.6mL solution for subcutaneous injection.
“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 at Fresenius Kabi USA. “With Fresenius Kabi’s heritage of quality manufacturing, supply reliability and extensive experience in oncology, I am confident the introduction of Stimufend will be the first of many examples of our commitment to biosimilars in the U.S.”
Fresenius Kabi is a leading producer of injectable medicines in the U.S. The company has more than 25 years of experience supplying oncology medications in the U.S. and one of the largest injectable portfolios in the industry with more than 30 products used in more than 460 different chemotherapy regimens. Additionally, more than 220 chemotherapy regimens can be supported entirely by administering Fresenius Kabi products.
“The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta. Health care providers and patients can be confident in Stimufend as a treatment option given its proven structural, functional and clinical similarity, including highly similar safety and tolerability profiles,” said Brandee Pappalardo, Ph.D., M.P.H., senior vice president and Chief Medical Officer for Fresenius Kabi USA. “Equally important to the clinical development of Stimufend is Fresenius Kabi’s dedication to providing patients with ongoing support.”
SOURCE: Businesswire