Pegfilgrastim biosimilar - Gedeon Richter

Drug Profile

Pegfilgrastim biosimilar - Gedeon Richter

Alternative Names: Cavoley - STADA Arzneimittel; Efgratin - Gedeon Richter; Pegylated human granulocyte colony stimulating factor - Gedeon Richter; RGB-02

Latest Information Update: 30 Dec 2016

Price : $50

At a glance

  • Originator Gedeon Richter
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Submission Withdrawal Neutropenia

Most Recent Events

  • 16 Nov 2016 Regulatory submission withdrawn for Neutropenia in European Union (SC) ,,
  • 08 Dec 2015 Preregistration for Neutropenia in European Union (SC)
  • 08 Apr 2015 Gedeon Richter completes a phase III trial in Neutropenia in Hungary (EudraCT2013-003166-14)
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