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NOVEMBER 5, 2019

FDA Approves Ziextenzo Pegfilgrastim Biosimilar

The FDA approved pegfilgrastim-bmez (Ziextenzo, Sandoz), a new biosimilar to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia.

Ziextenzo is the third biosimilar to pegfilgrastim (Neulasta, Amgen).

The FDA approval of pegfilgrastim-bmez was based on analytical, preclinical and clinical research, including data from a pivotal three-way