Posted by Michael Wonder on 05 Nov 2019
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy.
Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.
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.
