Pegfilgrastim biosimilar - Biocon/Mylan

Drug Profile

Pegfilgrastim biosimilar - Biocon/Mylan

Alternative Names: Fulphila; MYL 1401H; PEG G CSF

Latest Information Update: 28 Jan 2018

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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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Febrile neutropenia
  • Phase III Autoimmune disorders; Cancer

Most Recent Events

  • 28 Feb 2018 Mylan expects to launch pegfilgrastim biosimilar for Febrile neutropenia in USA in 2018
  • 28 Jan 2018 No recent reports of development identified for phase-I development in Autoimmune-disorders(In volunteers) in Netherlands (Parenteral)
  • 28 Jan 2018 No recent reports of development identified for phase-I development in Cancer(In volunteers) in Netherlands (Parenteral)
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