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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) ยท Commercial partner or holder: Biocon (import)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOAug 2006permitted
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 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
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All epoetin alfa and zeta biosimilars

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Data current to September 2026.