Pegfilgrastim biosimilar - Sandoz

Drug Profile

Pegfilgrastim biosimilar - Sandoz

Alternative Names: LA-EP2006; Zioxtenzo

Latest Information Update: 30 Oct 2017

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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

  • 27 Oct 2017 Preregistration for Febrile neutropenia (Prevention) in European Union (SC)
  • 27 Jan 2017 Regulatory submission withdrawn for Febrile neutropenia (Prevention) in European Union (SC) due to inability to submit required additional data within the timeframe
  • 06 Dec 2016 Pooled efficacy and adverse event data from phase trials PROTECT1 and PROTECT2 in Febrile neutropenia presented at the 39th Annual San Antonio Breast Cancer Symposium (SABCS 2016)
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