Biosimilar Nivestym Gets FDA Approval

The biosimilar was approved for all eligible indications of the reference product.
The biosimilar was approved for all eligible indications of the reference product.

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.

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For more information visit Pfizer.com.