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 · Company profile
FDAMar 2026approved
EMANov 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
About Ponlimsi / Degevma
Ponlimsi and Degevma are Teva's denosumab, approved in Europe in November 2025. Ponlimsi was approved in the United States in March 2026 and is interchangeable. Teva has developed a small number of biosimilars in-house and this is one of them, alongside its licensed adalimumab and ustekinumab from Alvotech.
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
Reference product in the Purple Book
Prolia
Marketing status (Purple Book)
Prescription, marketed
Presentations
60 mg/mL PFS
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Ponlimsi
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Ponlimsi
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
60 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
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.
Other developers in the same markets
Where Ponlimsi / Degevma holds an approval, these are the other denosumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 9 | Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| EMA | 11 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Enzene Biosciences (Osqay / Enzene denosumab), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| MHRA | 10 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Fresenius Kabi (Conexxence / Bomyntra), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Teva: Ovaleap, Ranopto, Teriparatide Teva, Tevagrastim / Ratiograstim.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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