Darbepoetin Alfa BS Sanwa
Darbepoetin alfa biosimilar developed by Sanwa Kagaku Kenkyusho. Reference product Aranesp (Nesp in Japan).
Brands by market: Darbepoetin Alfa BS Sanwa (Japan) · Commercial partner or holder: Sanwa Kagaku Kenkyusho · 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
About Darbepoetin Alfa BS Sanwa
Darbepoetin Alfa BS Sanwa is Sanwa Kagaku Kenkyusho's darbepoetin, approved in Japan in September 2019 alongside the JCR and Mylan products. Sanwa is a Japanese company specialising in kidney disease medicines.
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 Sanwa
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Darbepoetin Alfa BS Sanwa
Holder or applicant
Sanwa Kagaku Kenkyusho
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 2.
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 Sanwa holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| PMDA | 2 | JCR Pharmaceuticals (Darbepoetin Alfa BS JCR), Viatris (Darbepoetin Alfa BS MYL) |
Chronology
- PMDASep 2019Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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