Denosumab Ascend
Denosumab biosimilar developed by Ascend. Reference product Prolia and Xgeva.
Brands by market: Denosumab Ascend (EU, positive opinion June 2026) · Commercial partner or holder: Ascend
FDAnot listed
EMAunder review
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Denosumab Ascend
European Medicines Agency and European CommissionUnder reviewBrand
Denosumab Ascend
Holder or applicant
Ascend GmbH
Pathway
Centralised (Article 10(4))
Status
CHMP positive opinion Jun 2026; European Commission decision pending
Presentations
see SmPC
Note
CHMP positive opinion 25 June 2026; Commission decision pending.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2026CHMP positive opinion for Denosumab Ascend
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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