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Biocon epoetin

Epoetin alfa and zeta biosimilar developed by Not stated in the CDSCO list. Reference product Eprex (Epogen and Procrit in the United States).

Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Biocon (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2006permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Epoetin alfa and zetamoleculeNot stated in the CDSCO listdeveloper1 of 7markets0trials behind it0other products, same developer4rival developers in its markets

About Biocon epoetin

Biocon has held an Indian import permission for epoetin since 2006, in three strengths, for kidney anaemia. The published list does not name the manufacturer of the imported product.

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 OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Biocon Limited
Pathway
Import and marketing permission
Approved
Aug 2006
Application or permission
Import permission; bulk 31 July 2007 and 27 February 2013
Indications as licensed
Anaemia due to chronic renal failure
Presentations
2,000, 4,000 and 10,000 IU vials
Source
S013 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Biocon epoetin holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO4Bioviz Technologies (Bioviz epoetin), Not stated in the CDSCO list (Cipla epoetin), Wockhardt (Wockhardt epoetin), Zydus Lifesciences (Zydus epoetin)

Chronology

Sources

All epoetin alfa and zeta biosimilars

Planning epoetin alfa and zeta biosimilar development?

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Data current to September 2026.