Pegfilgrastim biosimilar - Coherus BioSciences

Drug Profile

Pegfilgrastim biosimilar - Coherus BioSciences

Alternative Names: CHS-1701

Latest Information Update: 17 May 2018

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At a glance

  • Originator Coherus Biosciences
  • Developer Coherus BioSciences
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Granulocyte colony stimulating factor receptor agonists; 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
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Neutropenia

Most Recent Events

  • 14 May 2018 FDA assigns Biosimilar User Fee Act (BsUFA) action date of 03/11/2018 for Pegfilgrastim biosimilar for Neutropenia
  • 14 May 2018 Us FDA accepts BLA for Pegfilgrastim biosimilar for Neutropenia for review
  • 03 May 2018 Coherus BioSciences re-submits BLA to the US FDA for Neutropenia in USA
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