Lupin denosumab
Denosumab biosimilar developed by Lupin. Reference product Prolia and Xgeva.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Lupin
FDAnot listed
EMAnot listed
CDSCOJun 2026permitted
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 OrganisationApprovedBrand
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2026CDSCO permission granted
Sources
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