Darbepoetin Alfa BS MYL
Darbepoetin alfa biosimilar developed by Mylan (Viatris). Reference product Aranesp (Nesp in Japan).
Brands by market: Darbepoetin Alfa BS MYL (Japan) · Commercial partner or holder: Mylan (Viatris)
FDAnot listed
EMAnot listed
PMDASep 2019approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan · Darbepoetin Alfa BS MYL
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Darbepoetin Alfa BS MYL
Holder or applicant
Mylan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2019
Indications as licensed
Nephrogenic anaemia
Presentations
5 to 180 microgram syringes
Note
Darbepoetin Alfa Biosimilar 3; discontinued from marketing.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2019Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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