On July 20, the U.S. Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), 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. Institutions President, Pfizer Essential Health.
The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of filgrastim-aafi compared to its reference product.
In the United States, filgrastim-aafi is indicated:
Filgrastim-aafi is expected to be available in the United States at a significant discount to the current wholesale acquisition cost of filgrastim. The wholesale acquisition cost is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.