Gennova pegfilgrastim
Pegfilgrastim biosimilar developed by Gennova Biopharmaceuticals (Emcure). Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Gennova Biopharmaceuticals
FDAnot listed
EMAnot listed
CDSCOJan 2010permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Gennova Biopharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2010
Application or permission
MF-104/10
Indications as licensed
Prevention of neutropenia in patients receiving cancer chemotherapy
Presentations
6 mg/0.6 mL PFS
Note
First pegfilgrastim biosimilar in the published CDSCO lists.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2010CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning pegfilgrastim biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.