Home/Biosimilar Atlas/Denosumab/Bildyos / Bilprevda

Bildyos / Bilprevda

Denosumab biosimilar developed by Shanghai Henlius Biotech, development code HLX14. Reference product Prolia and Xgeva.

Brands by market: Bildyos and Bilprevda (USA, EU) · Commercial partner or holder: Organon (USA, EU); Sciencepharma (EU holder) · Company profile
FDAAug 2025approved
EMASep 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCMar 2026approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
DenosumabmoleculeShanghai Henlius Biotechdeveloper4 of 7markets0trials behind it2other products, same developer12rival developers in its markets

About Bildyos / Bilprevda

Bildyos and Bilprevda are Henlius's denosumab, sold in the United States and Europe by Organon. The United States approved them in August 2025, interchangeable from October, and Europe in September 2025. In Canada the pair was approved in March 2026, the cancer form under the name Tuzemty. The European licence is held through Sciencepharma, a Polish company.

Status by market

FDA

United States · Bildyos

US Food and Drug AdministrationApproved
Brand
Bildyos
Holder or applicant
Shanghai Henlius Biotech, Inc.
Pathway
351(k)
Approved
Aug 2025
Application or permission
761444
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 · Bilprevda

US Food and Drug AdministrationApproved
Brand
Bilprevda
Holder or applicant
Shanghai Henlius Biotech, Inc.
Pathway
351(k)
Approved
Aug 2025
Application or permission
761444
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 · Bilprevda

European Medicines Agency and European CommissionApproved
Brand
Bilprevda
Holder or applicant
Sciencepharma Sp. z o.o
Pathway
Centralised (Article 10(4))
Approved
Sep 2025
Application or permission
EMEA/H/C/006435
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Bildyos

European Medicines Agency and European CommissionApproved
Brand
Bildyos
Holder or applicant
Sciencepharma Sp. z o.o
Pathway
Centralised (Article 10(4))
Approved
Sep 2025
Application or permission
EMEA/H/C/006434
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Bildyos

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Bildyos
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
MHRA

United Kingdom · Bilprevda

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Bilprevda
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
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Bildyos

Health CanadaApproved
Brand
Bildyos
Holder or applicant
Shanghai Henlius Biotech, INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Mar 2026
Application or permission
DIN 02565951
Presentations
60 mg
Source
S022 (Health Canada) · checked Sep 2026
HC

Canada · Tuzemty

Health CanadaApproved
Brand
Tuzemty
Holder or applicant
Shanghai Henlius Biotech, INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Mar 2026
Application or permission
DIN 02566001
Presentations
120 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Bildyos / Bilprevda holds an approval, these are the other denosumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA9Biocon 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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
EMA11Alvotech (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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
MHRA10Alvotech (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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
HC3Apotex (Denoza), Celltrion (Stoboclo / Osenvelt), Sandoz (Jubbonti / Wyost)

Same developer, other molecules

Other biosimilars in the Atlas developed by Shanghai Henlius Biotech: Hercessi / Zercepac, Poherdy.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.