FDA Approves Filgrastim Biosimilar Filgrastim-aafi

July 23, 2018 – On July 20, the U.S. Food and Drug Administration (FDA) approved filgrastim-aafi, a biosimilar to filgrastim, for all eligible indications of the reference product. “The FDA approval of filgrastim-aafi 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,” said Berk Gurdogan, U.S. … (leggi tutto)