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Second filgrastim biosimilar approved by FDA

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi), Pfizer press release

Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) was approved July 20 by the Food and Drug Administration, according to a statement provided by the agency. Nivestym is the second biosimilar to Neupogen to be approved in the United States.

Nivestym is approved for the same indications as Neupogen and can be prescribed for:

  • Patients with cancer receiving myelosuppressive chemotherapy.
  • Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
  • Patients with cancer undergoing bone marrow transplantation.
  • Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
  • Patients with severe chronic neutropenia.

Prescribing information is available here.

Citation:

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi), Pfizer press release