It was reported yesterday the US Food and Drug Administration (USFDA) has granted approval Novartis' Sandoz unit for Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen's Neulasta (pegfilgrastim).
The product has been indicated to decrease the chance of infection caused by low white blood cell count with a fever, a condition called febrile neutropenia. The biosimilar has been approved for use in patients with non-myeloid malignancies who are undergoing treatment with myelosuppressive anti-cancer drugs known for causing febrile neutropenia incidents as side effects.
Sandoz is expected to launch Ziextenzo in the US before the end of the year.
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