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Darbepoetin Alfa BS JCR

Darbepoetin alfa biosimilar developed by JCR Pharmaceuticals. Reference product Aranesp (Nesp in Japan).

Brands by market: Darbepoetin Alfa BS [JCR] (Japan) · Commercial partner or holder: JCR Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2019approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Darbepoetin alfamoleculeJCR Pharmaceuticalsdeveloper1 of 7markets0trials behind it2other products, same developer2rival developers in its markets

About Darbepoetin Alfa BS JCR

Darbepoetin Alfa BS JCR is one of three darbepoetin biosimilars approved in Japan on the same day in September 2019. JCR also holds Japan's epoetin 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 · Darbepoetin Alfa BS [JCR]

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
Darbepoetin Alfa BS [JCR]
Holder or applicant
JCR Pharmaceuticals
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2019
Indications as licensed
Nephrogenic anaemia
Presentations
5 to 180 microgram syringes
Remarks
Darbepoetin Alfa Biosimilar 1.
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.

Other developers in the same markets

Where Darbepoetin Alfa BS JCR holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA2Sanwa Kagaku Kenkyusho (Darbepoetin Alfa BS Sanwa), Viatris (Darbepoetin Alfa BS MYL)

Same developer, other molecules

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

Chronology

Sources

All darbepoetin alfa biosimilars

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Data current to September 2026.