Ziextenzo Third Biosimilar to Neulasta Approved for Febrile Neutropenia

December 2019, Vol 10, No 6 - FDA Approvals, News & Updates

On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to Neulasta were approved in 2018.

Pegfilgrastim-bmez is approved for the same indications as its reference drug—to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who receive myelosuppressive drugs (which are associated with an increased risk for febrile neutropenia). Pegfilgrastim-­bmez is not approved for the mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplant.

The FDA approval of pegfilgrastim-­bmez was based on data showing that it is highly similar to its reference drug, and that there are no clinically meaningful differences between these 2 drugs.