Conexxence / Bomyntra
Denosumab biosimilar developed by Fresenius Kabi, development code FKS518. Reference product Prolia and Xgeva.
Brands by market: Conexxence and Bomyntra (USA, EU) · Commercial partner or holder: Fresenius Kabi · Company profile
FDAMar 2025approved
EMAJul 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
About Conexxence / Bomyntra
Conexxence and Bomyntra are Fresenius Kabi's denosumab, approved in the United States in March 2025 and in Europe in July. Both are interchangeable in the United States. Fresenius Kabi, better known for its hospital products, has built a biosimilar range that now spans adalimumab, tocilizumab, pegfilgrastim and denosumab.
Status by market
FDA
United States · Conexxence
US Food and Drug AdministrationApprovedBrand
Conexxence
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Mar 2025
Application or permission
761398
Licence type
351(k) interchangeable, designated Oct 2025
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
FDA
United States · Bomyntra
US Food and Drug AdministrationApprovedBrand
Bomyntra
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Mar 2025
Application or permission
761398
Licence type
351(k) interchangeable, designated Oct 2025
Reference product in the Purple Book
Xgeva
Marketing status (Purple Book)
Prescription, marketed
Presentations
120 mg/1.7 mL vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Bomyntra
European Medicines Agency and European CommissionApprovedBrand
Bomyntra
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2025
Application or permission
EMEA/H/C/006269
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Conexxence
European Medicines Agency and European CommissionApprovedBrand
Conexxence
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2025
Application or permission
EMEA/H/C/006268
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Bomyntra
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Bomyntra
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
120 mg syringe and vial
Source
S023 (MHRA Products) · checked Sep 2026
MHRA
United Kingdom · Conexxence
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Conexxence
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.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Conexxence / Bomyntra by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| FKS518 | Fresenius Kabi | Prolia | Phase 3 | Comparative efficacy | Completed | Jun 2021 | Aug 2023 | NCT04934072 |
Other developers in the same markets
Where Conexxence / Bomyntra 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), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), 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), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
| MHRA | 10 | Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), Celltrion (Stoboclo / Osenvelt), Gedeon Richter (Enoby / Xtrenbo / Junod / Yaxwer), Intas Pharmaceuticals (Osvyrti / Jubereq), Samsung Bioepis (Ospomyv / Xbryk / Obodence), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Fresenius Kabi: Elonox, Idacio, Stimufend, Tyenne.
Chronology
- FDAMar 2025Approved by FDA as Bomyntra
- FDAMar 2025Approved by FDA as Conexxence
- EMAJul 2025Authorised by the European Commission as Bomyntra
- EMAJul 2025Authorised by the European Commission as Conexxence
- FDAOct 2025Bomyntra designated interchangeable
- FDAOct 2025Conexxence designated interchangeable
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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