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FDA approves Nivestym, biosimilar to Neupogen, for treatment of neutropenia
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The FDA approved the biosimilar filgrastim-aafi, designed to promote white blood cell recovery among individuals who have undergone treatments that can trigger neutropenia.
Filgrastim-aafi (Nivestym, Pfizer) is the second approved biosimilar to filgrastim (Neupogen, Amgen), a granulocyte-colony stimulating factor. The other — filgrastim-sndz (Zarxio, Sandoz) — received FDA approval in 2015.
Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.
Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.
Both filgrastim-aafi and filgrastim-sndz are approved for the same five indications as their reference product, filgrastim.
These include treatment of patients with cancer who are receiving myelosuppressive chemotherapy, those with acute myeloid leukemia who receive induction or consolidation chemotherapy, individuals with cancer who are undergoing bone marrow transplantation, patients with cancer who are undergoing autologous peripheral blood progenitor cell collection and therapy, and those with severe chronic neutropenia.
The most common side effects associated with filgrastim-aafi treatment include aching in the bones or muscles, as well as redness, swelling or itching at the injection side, according to an FDA-issued press release. Serious side effects may include spleen rupture, allergic reactions, fast pulse or sweating, or acute respiratory distress syndrome.