{"id":54009,"date":"2023-02-16T17:03:27","date_gmt":"2023-02-16T16:03:27","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/stimufend-pegfilgrastim-fpgk-now-available-in-the-united-states\/"},"modified":"2023-02-16T17:03:27","modified_gmt":"2023-02-16T16:03:27","slug":"stimufend-pegfilgrastim-fpgk-now-available-in-the-united-states","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/stimufend-pegfilgrastim-fpgk-now-available-in-the-united-states\/","title":{"rendered":"Stimufend\u00ae (pegfilgrastim-fpgk) Now Available in the United States"},"content":{"rendered":"
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\nFresenius Kabi introduces its first biosimilar in the U.S.<\/b>\n<\/p>\n

\nExtensive experience in oncology and commitment to patients highlight company\u2019s portfolio expansion<\/b>\n<\/p>\n

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#FreseniusKabi<\/a>–Fresenius Kabi announced today the immediate availability in the U.S. of Stimufend<\/a>\u00ae<\/sup> (pegfilgrastim-fpgk), the company\u2019s biosimilar to Neulasta\u00ae<\/sup> (pegfilgrastim), 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.\n<\/p>\n

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\n\u201cFresenius 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,\u201d said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. \u201cWith Fresenius Kabi\u2019s 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.\u201d\n<\/p>\n

\nFresenius 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.\n<\/p>\n

\n\u201cThe 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,\u201d said Brandee Pappalardo, Ph.D., M.P.H., senior vice president and Chief Medical Officer for Fresenius Kabi USA. \u201cEqually important to the clinical development of Stimufend is Fresenius Kabi\u2019s dedication to providing patients with ongoing support.\u201d\n<\/p>\n

\nTo learn more about how Fresenius Kabi provides comprehensive patient support for Stimufend\u00ae<\/sup> please click here<\/a>.\n<\/p>\n

\nStimufend\u00ae<\/sup> is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.\n<\/p>\n

\nLimitations of Use: <\/span>Stimufend\u00ae<\/sup> is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n

\nContraindication<\/b>\n<\/p>\n