Home/Biosimilar Atlas/Darbepoetin alfa/Darbepoetin Alfa BS MYL

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) · 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 alfamoleculeMylandeveloper1 of 7markets0trials behind it1other products, same developer2rival developers in its markets

About Darbepoetin Alfa BS MYL

Darbepoetin Alfa BS MYL was Mylan's darbepoetin for Japan, approved in September 2019 and since discontinued. It remains on the PMDA list as an approved product.

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 MYL

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Darbepoetin Alfa Biosimilar 3; discontinued from marketing.
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 MYL holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA2JCR Pharmaceuticals (Darbepoetin Alfa BS JCR), Sanwa Kagaku Kenkyusho (Darbepoetin Alfa BS Sanwa)

Same developer, other molecules

Other biosimilars in the Atlas developed by Viatris: Lextemy.

Chronology

Sources

All darbepoetin alfa biosimilars

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Data current to September 2026.