Hetero darbepoetin alfa
Darbepoetin alfa biosimilar developed by Hetero Drugs. Reference product Aranesp (Nesp in Japan).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Hetero Drugs
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOJan 2014permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
Hetero Drugs Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2014
Application or permission
MF-296/2013; BULK-297/2013
Indications as licensed
Anaemia of chronic renal failure
Presentations
Injection
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2014CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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