Pegfilgrastim biosimilar - Biocon/Mylan

Drug Profile

Pegfilgrastim biosimilar - Biocon/Mylan

Alternative Names: MYL 1401H; PEG G CSF

Latest Information Update: 01 Dec 2016

Price : $50

At a glance

  • Originator Biocon
  • Developer Biocon; Mylan
  • 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Phase III Autoimmune disorders; Cancer; Febrile neutropenia

Most Recent Events

  • 07 Oct 2016 Efficacy and adverse event data from a phase III trial in Febrile Neutropenia (Chemotherapy-Induced were presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
  • 07 Oct 2016 Mylan presented adverse events, pharmacokinetics and pharmacodynamics data from phase I study in healthy volunteers at the 41st European Society for Medical Oncology Congress 2016 (ESMO-2016)
  • 21 Jul 2016 EMA accepts MAA for pegfilgrastim biosimilar for Cancer for review
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