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Reliance Life Sciences denosumab

Denosumab biosimilar developed by Reliance Life Sciences. Reference product Prolia and Xgeva.

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
CDSCODec 2022permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
DenosumabmoleculeReliance Life Sciencesdeveloper1 of 7markets0trials behind it13other products, same developer4rival developers in its markets

About Reliance Life Sciences denosumab

Reliance Life Sciences received its denosumab permission in India in December 2022 for osteoporosis, and added the cancer dose and giant cell tumour of bone in 2025. It is the third Indian company to make denosumab, after Intas and Enzene.

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
Dec 2022
Application or permission
MF/BIO/22/000133; additional indication MF/BIO/25/000062
Indications as licensed
Postmenopausal osteoporosis at permission; giant cell tumour of bone added April 2025
Presentations
60 mg/mL PFS and vial; 120 mg/1.7 mL vial (2025)
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO4Enzene Biosciences (Osqay / Enzene denosumab), Hetero (Hetero denosumab), Intas Pharmaceuticals (Osvyrti / Jubereq), Lupin (Lupin denosumab)

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 darbepoetin alfa, 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 denosumab biosimilars

Planning denosumab biosimilar development?

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Data current to September 2026.