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
FDAMar 2025approved
EMAJul 2025authorised
CDSCOnot listed
EDEnot listed
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
Presentations
60 mg/mL PFS
Source
S001, S016
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
Presentations
120 mg/1.7 mL vial
Source
S001, S016
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
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
Planning denosumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.