Ponlimsi / Degevma
Denosumab biosimilar developed by Teva, development code TVB-009. Reference product Prolia and Xgeva.
Brands by market: Ponlimsi (USA, EU); Degevma (EU) · Commercial partner or holder: Teva
FDAMar 2026approved
EMANov 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Ponlimsi
US Food and Drug AdministrationApprovedBrand
Ponlimsi
Holder or applicant
Teva Pharmaceuticals, Inc.
Pathway
351(k)
Approved
Mar 2026
Application or permission
761385
Licence type
351(k) interchangeable, designated Mar 2026
Presentations
60 mg/mL PFS
Source
S001, S016
EMA
European Union · Degevma
European Medicines Agency and European CommissionApprovedBrand
Degevma
Holder or applicant
Teva GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006239
Presentations
see SmPC
Source
S017
EMA
European Union · Ponlimsi
European Medicines Agency and European CommissionApprovedBrand
Ponlimsi
Holder or applicant
Teva GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006238
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMANov 2025Authorised by the European Commission as Degevma
- EMANov 2025Authorised by the European Commission as Ponlimsi
- FDAMar 2026Approved by FDA as Ponlimsi
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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