Home/Biosimilar Atlas/Denosumab/Lupin denosumab

Lupin denosumab

Denosumab biosimilar developed by Lupin. Reference product Prolia and Xgeva.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Lupin · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2026permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
DenosumabmoleculeLupindeveloper1 of 7markets0trials behind it5other products, same developer4rival developers in its markets

About Lupin denosumab

Lupin received its denosumab permission in India in June 2026 for osteoporosis in women and men. It is the fifth Indian company to make denosumab and the most recent entrant. Lupin has taken its etanercept and ranibizumab to Europe and the United States, and denosumab may follow.

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
Lupin Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2026
Application or permission
MF/BIO/26/000084
Indications as licensed
Postmenopausal osteoporosis, male osteoporosis
Presentations
60 mg/mL PFS
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Lupin 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), Reliance Life Sciences (Reliance Life Sciences denosumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Lupin: Armlupeg / Lupin pegfilgrastim, Lupin filgrastim, Lupin insulin glargine, Nepexto / Fubelv / Lupin etanercept, Ranluspec / Vislyfa.

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.