Sandoz Gets Approval For US Pegfilgrastim
Becomes First To Offer Both Long- And Short-Acting Biosimilars
Sandoz has finally received a much-awaited FDA approval for its pegfilgrastim biosimilar, Ziextenzo, which will be launched in the US “as soon as possible this year.”
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Amgen has been rebuked by the FDA over promotion for its unique Neulasta Onpro on-body injector version of pegfilgrastim, in which the firm made false or misleading claims about its benefit compared to a pre-filled syringe formulation of pegfilgrastim, where biosimilar competition exists.
Lupin’s first US biosimilar application, for a rival to Neulasta, has been accepted for filing by the FDA. If approved, the product would join an already crowded market for pegfilgrastim in the US.
Initial market signals from Sandoz’ US launch of its Ziextenzo pegfilgrastim biosimilar are promising, global Biopharmaceuticals head Pierre Bourdage told Generics Bulletin.