Sandoz finally gains US FDA approval for biosimilar Ziextenzo
Swiss pharma giant Novartis’ (NOVN: VX) generics and biosimilars subsidiary Sandoz today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgrastim-bmez).
The FDA decision follows a previous rejection of the biosimilar application and a re-submission in April this year.
Sandoz biosimilar pegfilgrastim, which references Amgen’s (Nasdaq: AMGN) Neulasta, has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Global sales of Neulasta were down 32% at $711 million for the third-quarter of this year, as a results of lower net selling price and biosimilar competition. Sandoz now intends to launch Ziextenzo in the USA as soon as possible this year.
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