Pegfilgrastim biosimilar - Biocon/Mylan

Drug Profile

Pegfilgrastim biosimilar - Biocon/Mylan

Alternative Names: MYL 1401H; PEG G CSF

Latest Information Update: 08 Mar 2017

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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Febrile neutropenia
  • Phase III Autoimmune disorders; Cancer

Most Recent Events

  • 16 Feb 2017 Preregistration for Febrile neutropenia in USA before Feb 2017 (SC)
  • 16 Feb 2017 Planned Biosimilar User Fee Act (BsUFA) date for Febrile neutropenia in USA (SC) is 2017-10-09
  • 16 Feb 2017 The US FDA accepts BLA for pegfilgrastim biosimilar for Febrile Neutropenia for review
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