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 · Company profile
FDANot listed
EMAUnder review
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Not yet approved in any of the 7 markets
Connections
About Denosumab Ascend
Denosumab Ascend received a positive opinion from the European committee in June 2026, and the Commission's decision is awaited. Ascend, a German company, has not named the developer of the product. It will be the fourteenth denosumab holder in Europe when approved.
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
Remarks
CHMP positive opinion 25 June 2026; Commission decision pending.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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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