Home/Biosimilar Atlas/Denosumab/Stoboclo / Osenvelt

Stoboclo / Osenvelt

Denosumab biosimilar developed by Celltrion, development code CT-P41. Reference product Prolia and Xgeva.

Brands by market: Stoboclo and Osenvelt (USA, EU) · Commercial partner or holder: Celltrion · Company profile
FDAFeb 2025approved
EMAFeb 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCSep 2025approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
DenosumabmoleculeCelltriondeveloper4 of 7markets0trials behind it9other products, same developer12rival developers in its markets

About Stoboclo / Osenvelt

Stoboclo and Osenvelt are Celltrion's denosumab, approved in the United States and Europe within days of each other in February 2025, and in Canada in September. Both are interchangeable in the United States. Celltrion sells them itself in all three markets, unlike its earlier antibodies, which went through partners.

Status by market

FDA

United States · Stoboclo

US Food and Drug AdministrationApproved
Brand
Stoboclo
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761404
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 · Osenvelt

US Food and Drug AdministrationApproved
Brand
Osenvelt
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Feb 2025
Application or permission
761404
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 · Stoboclo

European Medicines Agency and European CommissionApproved
Brand
Stoboclo
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006156
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Osenvelt

European Medicines Agency and European CommissionApproved
Brand
Osenvelt
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006157
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Osenvelt

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Osenvelt
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
MHRA

United Kingdom · Stoboclo

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Stoboclo
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 · Osenvelt

Health CanadaApproved
Brand
Osenvelt
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Sep 2025
Application or permission
DIN 02560895
Presentations
120 mg
Source
S022 (Health Canada) · checked Sep 2026
HC

Canada · Stoboclo

Health CanadaApproved
Brand
Stoboclo
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Sep 2025
Application or permission
DIN 02560917
Presentations
60 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 Stoboclo / Osenvelt holds an approval, these are the other denosumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA9Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), 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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
EMA11Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), 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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
MHRA10Alvotech (Zvogra / Kefdensis / Xbonzy / Acvybra), Biocon Biologics (Bosaya / Aukelso / Vevzuo / Evfraxy), 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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
HC3Apotex (Denoza), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda)

Same developer, other molecules

Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Truxima / Blitzima, Vegzelma, Yuflyma.

Chronology

Sources

All denosumab biosimilars

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 consultant
Data current to September 2026.