Pegfilgrastim biosimilar - Bio-KerAlternative Names: G-CSF/PEG 20K
Latest Information Update: 25 Sep 2013
At a glance
- Originator Bio-Ker
- 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.
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.
- New Molecular Entity No
Highest Development Phases
- Phase I Unspecified
Most Recent Events
- 15 Mar 2016 Biomarkers information updated
- 11 Sep 2013 Phase-I clinical trials in Undefined indication (in volunteers) in Italy (Parenteral)