FDA grants Sandoz approval for Ziextenzo in oncology care

The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this year. The drug is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The Novartis division revealed that the the FDA approval was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study. In the study, Sandoz pegfilgrastim and US-sourced reference pegfilgrastim were compared with Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.