Osqay / Enzene denosumab
Denosumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Prolia and Xgeva.
Brands by market: Osqay (EU); brand not published by CDSCO (India) · Commercial partner or holder: Theramex (EU)
FDAnot listed
EMAJan 2026authorised
CDSCOJul 2021permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Osqay
European Medicines Agency and European CommissionApprovedBrand
Osqay
Holder or applicant
Theramex Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Jan 2026
Application or permission
EMEA/H/C/006492
Presentations
see SmPC
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jul 2021
Application or permission
MF/BIO/21/000062; bulk MF/BULK/BD/211/2021; additional indications MF/BIO/23/000031
Indications as licensed
Postmenopausal osteoporosis at permission; male osteoporosis and hormone-ablation bone loss added April 2023
Presentations
60 mg/mL PFS
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJul 2021CDSCO permission granted
- EMAJan 2026Authorised by the European Commission as Osqay
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)
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