Virchow Biotech pegfilgrastim
Pegfilgrastim biosimilar developed by Virchow Biotech. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Virchow Biotech
FDAnot listed
EMAnot listed
CDSCODec 2021permitted
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
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCODec 2021CDSCO permission granted
Sources
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