Pegfilgrastim biosimilar - Sandoz

Drug Profile

Pegfilgrastim biosimilar - Sandoz

Alternative Names: LA EP 2006; Ziextenzo

Latest Information Update: 25 Sep 2018

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At a glance

  • Originator Sandoz
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Febrile neutropenia

Most Recent Events

  • 21 Sep 2018 CHMP adopts positive opinion for marketing authorisation of pegfilgrastim biosimilar for Febrile neutropenia (Prevention) in European Union
  • 22 Feb 2018 Novartis announces intention to re-submit regulatory application to the US FDA for Febrile neutropenia in 2019 (Novartis pipeline, February 2018)
  • 08 Dec 2017 Pharmacokinetic data from phase I Pk PD trial in volunteers released by Sandoz
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