Drug Profile
Pegfilgrastim biosimilar - Gedeon Richter
Alternative Names: Cavoley - STADA Arzneimittel; Efgratin - Gedeon Richter; Pegylated human granulocyte colony stimulating factor - Gedeon Richter; RGB-02Latest Information Update: 25 Nov 2021
Price :
$50
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At a glance
- Originator Gedeon Richter
- Class Antineoplastics; Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Recombinant proteins
- Mechanism of Action Granulocyte colony stimulating factor receptor agonists; Granulocyte colony-stimulating factor replacements
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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 Submission Withdrawal Neutropenia
Most Recent Events
- 01 Feb 2019 Regulatory submission withdrawn for Neutropenia in European Union (SC)
- 01 Feb 2019 Gedeon Richter withdraws the resubmitted MAA for pegfilgrastim biosimilar for Neutropenia since it was unable to address the concerns raised by the CHMP within the given timeframe
- 02 Mar 2018 Preregistration for Neutropenia in European Union (SC)