Dr. Reddy's darbepoetin alfa
Darbepoetin alfa biosimilar developed by Dr. Reddy's Laboratories. Reference product Aranesp (Nesp in Japan).
About Dr. Reddy's darbepoetin alfa
Dr. Reddy's received the first darbepoetin permission in the world, in India in March 2010, for kidney anaemia, with a permission for the drug substance later that year.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Dr. Reddy's darbepoetin alfa holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 2 | Hetero (Hetero darbepoetin alfa), Reliance Life Sciences (Reliance Life Sciences darbepoetin alfa) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Dr. Reddy's Laboratories: Dr. Reddy's bevacizumab, Dr. Reddy's pegfilgrastim, Dr. Reddy's trastuzumab, Teriparatide Dr. Reddy's, Zimrixby / Ituxredi.
Chronology
- CDSCOMar 2010CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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