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Pegfilgrastim biosimilar - Amega Biotech

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Drug Profile

Pegfilgrastim biosimilar - Amega Biotech

Alternative Names: Peg-filgrastim biosimilar - Amega Biotech; Peg-Neutropine; Recombinant pegfilgrastim - Amega Biotech

Latest Information Update: 28 Apr 2025

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At a glance

  • Originator Amega Biotech
  • Developer Amega Biotech; Megalabs
  • Class Antineoplastics; Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Radioprotectives; 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

  • 28 Apr 2025 No recent reports of development identified for phase-I development in Neutropenia(In volunteers) in Uruguay (SC, Injection)
  • 18 Sep 2022 Megalabs completes a phase I pharmacokinetic trial in healthy volunteers in Uruguay(NCT04873765)
  • 25 Apr 2022 Megalabs initiates enrolment in a phase I pharmacokinetic trial in healthy volunteers in Uruguay(NCT04873765)

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