Zydus epoetin
Epoetin alfa and zeta biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Eprex (Epogen and Procrit in the United States).
About Zydus epoetin
Zydus, then Cadila Healthcare, received its epoetin permission in India in April 2010, with a permission for the drug substance in 2014. It is one of the earliest domestic manufacturing permissions in the published Indian lists.
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 Zydus epoetin holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 3 | Bioviz Technologies (Bioviz epoetin), Not stated in the CDSCO list (Cipla epoetin), Wockhardt (Wockhardt epoetin) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Zydus Lifesciences: Exemptia / Cadalimab, Nufymco, Zydus aflibercept, Zydus bevacizumab, Zydus follitropin alfa, Zydus peginterferon alfa-2b, Zydus pertuzumab, Zydus rituximab, Zydus teriparatide, Zydus trastuzumab.
Chronology
- CDSCOApr 2010CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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