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FDA Approves Filgrastim Biosimilar for AML

On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015.

Read the Pfizer corporate press release here.

Posted 7/23/2018