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Pegfilgrastim biosimilar - Biocon/Viatris

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Drug Profile

Pegfilgrastim biosimilar - Biocon/Viatris

Alternative Names: Fulphila; MYL 1401H; PEG G CSF; pegfilgrastim-jmdb

Latest Information Update: 03 Aug 2023

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At a glance

  • Originator Biocon
  • Developer Biocon; Viatris Inc
  • 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 Chemotherapy induced febrile neutropenia; Febrile neutropenia
  • Phase III Autoimmune disorders; Cancer

Most Recent Events

  • 03 Aug 2023 Pegfilgrastim biosimilar is registered for Febrile neutropenia in New Zealand (Biocon website, August 2023)
  • 03 Aug 2023 Launched for Chemotherapy induced febrile neutropenia in Singapore, Poland, Netherlands, Austria, France, Finland, Malaysia, Switzerland, Sweden, Germany, Israel (SC)
  • 03 Aug 2023 Registered for Chemotherapy induced febrile neutropenia in New Zealand (SC) (Biocon website, August 2023)

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