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FDA Approves Second Filgrastim Biosimilar

Jason Harris
Published: Monday, Jul 23, 2018

The FDA approved filgrastim-aafi (Nivestym), a filgrastim (Neupogen) biosimilar, to prevent and treat side effects associated with cancer treatment, including febrile neutropenia and severe neutropenia.

 
Pfizer, the maker of filgrastim-aafi, issued a press release July 20 announcing the agency’s decision.

“The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” Berk Gurdogan, US Institutions president for Pfizer Essential Health, said in a statement. “We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

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