FDA Approves Second Filgrastim Biosimilar

The Food and Drug Administration approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), for all eligible indications of the original product.

The Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), for all eligible indications of the original product.

Filgrastim-aafi is indicated to treat chemotherapy-induced febrile neutropenia, acute myeloid leukemia, patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia.

“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, U.S. Institutions president of Pfizer Essential Health, said in a press release.

The approval included a review of a comprehensive data package and totality of evidence that demonstrated a high degree of similarity between filgrastim-aafi and filgrastim.

“We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients,” Gurdogan added.

The most common adverse events (AEs) of filgrastim-aafi include aching in the bones and muscles; and serious AEs are spleen rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, kidney injury, capillary leak syndrome, thrombocytopenia, leukocytosis, and cutaneous vasculitis.