Epoetin Alfa BS JCR

Epoetin alfa and zeta biosimilar developed by JCR Pharmaceuticals. Reference product Eprex (Epogen and Procrit in the United States).

Brands by market: Epoetin Alfa BS [JCR] (Japan) · Commercial partner or holder: JCR Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDAJan 2010approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Epoetin Alfa BS JCR

Epoetin Alfa BS JCR was the second biosimilar approved in Japan, in January 2010, after Sandoz's somatropin. Its Japanese non-proprietary name is epoetin kappa, and its reference product is Espo. JCR, based in Kobe, went on to approve darbepoetin and agalsidase beta biosimilars.

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 · Epoetin Alfa BS [JCR]

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
Epoetin Alfa BS [JCR]
Holder or applicant
JCR Pharmaceuticals
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jan 2010
Indications as licensed
Renal anaemia on dialysis; anaemia of prematurity
Presentations
750, 1,500 and 3,000 IU syringes
Remarks
The INN in Japan is epoetin kappa; reference product Espo. The second biosimilar approved in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Same developer, other molecules

Other biosimilars in the Atlas developed by JCR Pharmaceuticals: Agalsidase Beta BS JCR, Darbepoetin Alfa BS JCR.

Chronology

Sources

All epoetin alfa and zeta biosimilars

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Data current to September 2026.