FDA Approves Nivestym for Acute Myeloid Leukemia and More

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

Nivestym 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.

A biosimilar is a biological product that is highly similar to the structure and function and has no clinically meaningful differences from an existing FDA-approved reference product. The approval included a review of a comprehensive data package and totality of evidence that demonstrated a high degree of similarity between Nivestym and Neupogen.

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