Sandoz gets FDA green light for Neulasta biosimilar Ziextenzo
Sandoz has received the Food and Drug Administration’s blessing for Ziextenzo (pegfilgrastim-bmez), the company's biosimilar of Amgen's Neulasta.
Ziextenzo 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.
“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” said Sandoz president Carol Lynch. “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 United States – including consistent product supply and reliable patient services.”
Sandoz expects to launch the product this year.