Pegfilgrastim biosimilar - Biocon/Mylan

Drug Profile

Pegfilgrastim biosimilar - Biocon/Mylan

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

Latest Information Update: 05 Dec 2017

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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

  • 30 Nov 2017 European Medicines Agency re-accepts MAA for pegfilgrastim biosimilar (Chemotherapy-induced) for Febrile neutropenia for review
  • 07 Nov 2017 Regulatory submission resumed for Febrile neutropenia (Chemotherapy-induced) in European Union (SC)
  • 10 Oct 2017 Mylan receives complete response letter from the FDA for pegfilgrastim biosimilar in Febrile neutropenia
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