Nivestym, a Biosimilar to Neupogen, Approved by FDA

Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Neupogen, has been approved by the U.S. Food and Drug Administration (FDA) for all eligible indications of the reference product. Approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nivestym compared to Neupogen.

Nivestym is indicated:

• To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever;

• For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia;

• To reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation;

• For the mobilization of autologous hematopoietic progenitor cellsinto the peripheral blood for collection by leukapheresis; and

• For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia.

Nivestym is expected to be available in the U.S. at a significant discount to the current wholesale acquisition cost of Neupogen. It is Pfizer’s fourth biosimilar approved by FDA.