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Reliance Life Sciences darbepoetin alfa

Darbepoetin alfa biosimilar developed by Reliance Life Sciences. Reference product Aranesp (Nesp in Japan).

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Reliance Life Sciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2016permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Darbepoetin alfamoleculeReliance Life Sciencesdeveloper1 of 7markets0trials behind it13other products, same developer2rival developers in its markets

About Reliance Life Sciences darbepoetin alfa

Reliance Life Sciences received its darbepoetin permission in India in June 2016, covering both kidney anaemia and anaemia from chemotherapy, the broadest Indian darbepoetin label.

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

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2016
Application or permission
MF-91/2016; BULK-92/2016
Indications as licensed
Anaemia of chronic kidney disease; chemotherapy-induced anaemia in non-myeloid malignancy
Presentations
Injection
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Reliance Life Sciences darbepoetin alfa holds an approval, these are the other darbepoetin alfa biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Dr. Reddy's Laboratories (Dr. Reddy's darbepoetin alfa), Hetero (Hetero darbepoetin alfa)

Same developer, other molecules

Other biosimilars in the Atlas developed by Reliance Life Sciences: Reliance Life Sciences adalimumab, Reliance Life Sciences bevacizumab, Reliance Life Sciences denosumab, Reliance Life Sciences etanercept, Reliance Life Sciences follitropin alfa, Reliance Life Sciences golimumab, Reliance Life Sciences infliximab, Reliance Life Sciences omalizumab, Reliance Life Sciences ranibizumab, Reliance Life Sciences rituximab, Reliance Life Sciences somatropin, Reliance Life Sciences trastuzumab, UstekiRel.

Chronology

Sources

All darbepoetin alfa biosimilars

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Data current to September 2026.