The FDA approved biosimilar pegfilgrastim-bmez (Ziextenzo, Sandoz) for the prevention of incidence of infection, as presented by febrile neutropenia among patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, according to a press release.
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“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” Carol Lynch, president of Sandoz, said in the release. “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services.”
The FDA based the approval pegfilgrastim-bmez on an analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics and pharmacodynamics study. The study resulted in no clinically meaningful differences regarding safety and immunogenicity between pegfilgrastim-bmez and US reference pegfilgrastim; pegfilgrastim-bmez and EU reference pegfilgrastim; and US-sourced with EU-sourced reference pegfilgrastim.