USV pegfilgrastim
Pegfilgrastim biosimilar developed by USV. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: USV
FDAnot listed
EMAnot listed
CDSCOSep 2019permitted
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
USV Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2019
Application or permission
MF/BIO/19/000044; drug substance MF/BIO/20/000030 (April 2020)
Indications as licensed
Neutropenia in cytotoxic chemotherapy for non-myeloid malignancy
Presentations
6 mg/0.6 mL PFS
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2019CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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