USV pegfilgrastim
Pegfilgrastim biosimilar developed by USV. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: USV · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOSep 2019permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About USV pegfilgrastim
USV received its pegfilgrastim permission in India in September 2019, with a permission for the drug substance the following year. USV also makes teriparatide and somatropin for the Indian market.
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
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where USV 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), Virchow Biotech (Virchow Biotech pegfilgrastim), Wockhardt (Wockhardt pegfilgrastim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by USV: USV somatropin, USV teriparatide.
Chronology
- CDSCOSep 2019CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning pegfilgrastim biosimilar development?
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