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Filgrastim biosimilar - Kashiv BioSciences

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Drug Profile

Filgrastim biosimilar - Kashiv BioSciences

Alternative Names: Filgrastim-ayow; RELEUKO

Latest Information Update: 24 Nov 2022

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At a glance

  • Originator Therapeutic Proteins International
  • Developer Amneal Pharmaceuticals; Kashiv BioSciences
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Neuroprotectants; Recombinant proteins
  • Mechanism of Action Granulocyte colony stimulating factor replacements; Granulocyte colony-stimulating factor receptor agonists
  • 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

  • Marketed Neutropenia

Most Recent Events

  • 22 Nov 2022 Launched for Neutropenia in USA (SC, 300mcg/0.5ml/vial)
  • 01 Mar 2022 Amneal Pharmaceuticals plans to launch filgrastim ayow for Neutropenia in USA in the third quarter of 2022
  • 01 Mar 2022 US FDA approves the BLA for filgrastim biosimilar for Neutropenia

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