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) · Commercial partner or holder: Hetero Drugs · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJan 2014permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Hetero darbepoetin alfa
Hetero received its darbepoetin permission in India in January 2014, the second Indian maker, for kidney anaemia.
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
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Hetero darbepoetin alfa holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 2 | Dr. Reddy's Laboratories (Dr. Reddy's darbepoetin alfa), Reliance Life Sciences (Reliance Life Sciences darbepoetin alfa) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Hetero: Hetero bevacizumab, Hetero denosumab, Hetero rituximab, Mabura.
Chronology
- CDSCOJan 2014CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning darbepoetin alfa biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.