FDA/CDC

FDA approves Nivestym, second biosimilar to Neupogen


 

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.

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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.

According to a press release from Pfizer, the manufacturer of the biosimilar, Nivestym is expected to be available in the United States at a significant discount to the current wholesale acquisition cost of Neupogen, which is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.

The FDA statement notes that a biosimilar is approved based on a showing that it is highly similar to an already approved biologic product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Prescribing information is available here.

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