Wockhardt pegfilgrastim
Pegfilgrastim biosimilar developed by Wockhardt. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Wockhardt · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2015permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Wockhardt pegfilgrastim
Wockhardt received its pegfilgrastim permission in India in February 2015, in a syringe and a vial, adding to its insulin and erythropoietin range.
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
Wockhardt Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2015
Application or permission
MF-41/2015
Indications as licensed
Prevention of neutropenia in myelosuppressive chemotherapy
Presentations
6 mg/0.6 mL PFS and vial
Source
S014 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Wockhardt 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), Virchow Biotech (Virchow Biotech pegfilgrastim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Wockhardt: Wockhardt epoetin, Wockhardt insulin glargine.
Chronology
- CDSCOFeb 2015CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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