Biosimilar Nivestym Gets FDA Approval

The Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi; Pfizer), a biosimilar to Neupogen (filgrastim; Amgen). The approval was based on data demonstrating that the biosimilar product and the reference product are highly similar, and that there are no clinically meaningful differences between the 2 agents.

Nivestym, a leukocyte growth factor, is approved to:

• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia.
• 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.
• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
• Reduce the incidence and duration of sequelae of severe neutropenia in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Nivestym will be available in single-dose vials and single-dose prefilled syringes containing 300mcg or 480mcg preservative-free filgrastim-aafi solution.

For more information visit Pfizer.com.