Virchow Biotech pegfilgrastim
Pegfilgrastim biosimilar developed by Virchow Biotech. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Virchow Biotech · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCODec 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Virchow Biotech pegfilgrastim
Virchow Biotech received its pegfilgrastim permission in India in December 2021, its first biosimilar, followed by rituximab in 2025.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Virchow Biotech Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Dec 2021
Application or permission
MF/BIO/21/000140
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
6 mg/0.6 mL PFS
Source
S011 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Virchow Biotech pegfilgrastim holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 5 | Dr. Reddy's Laboratories (Dr. Reddy's pegfilgrastim), Gennova Biopharmaceuticals (Gennova pegfilgrastim), Lupin (Armlupeg / Lupin pegfilgrastim), USV (USV pegfilgrastim), Wockhardt (Wockhardt pegfilgrastim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Virchow Biotech: Virchow Biotech rituximab.
Chronology
- CDSCODec 2021CDSCO permission granted
Sources
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.