Therapy Areas: Oncology
USFDA grants approval to Sandoz unit for Ziextenzo
7 November 2019 -

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.