Home/Biosimilar Atlas/Denosumab/Reliance Life Sciences denosumab

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) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCODec 2022permitted
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

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
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All denosumab biosimilars

Planning denosumab biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Talk to a biosimilar regulatory consultant
Data current to September 2026.