Home/Biosimilar Atlas/Denosumab/Osqay / Enzene denosumab

Osqay / Enzene denosumab

Denosumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Prolia and Xgeva.

Brands by market: Osqay (EU); brand not published by CDSCO (India) · Commercial partner or holder: Theramex (EU) · Company profile
FDANot listed
EMAJan 2026authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJul 2021permitted
EDENot listed
Approved or registered in 2 of 7 markets
Connections
DenosumabmoleculeEnzene Biosciencesdeveloper2 of 7markets2trials behind it5other products, same developer14rival developers in its markets

About Osqay / Enzene denosumab

Enzene's denosumab was permitted in India in 2021 and reached Europe in January 2026 as Osqay, sold by Theramex. It is the first Enzene product to gain a Western approval. Enzene, part of Alkem, is one of the newer Indian biosimilar developers, and Theramex specialises in women's health, where the osteoporosis use sits.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Osqay

European Medicines Agency and European CommissionApproved
Brand
Osqay
Holder or applicant
Theramex Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Jan 2026
Application or permission
EMEA/H/C/006492
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jul 2021
Application or permission
MF/BIO/21/000062; bulk MF/BULK/BD/211/2021; additional indications MF/BIO/23/000031
Indications as licensed
Postmenopausal osteoporosis at permission; male osteoporosis and hormone-ablation bone loss added April 2023
Presentations
60 mg/mL PFS
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Osqay / Enzene denosumab by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
ENZ215Enzene BiosciencesProliaPhase 1Comparative PKCompletedJan 2022May 2024NCT05245669
ENZ215Enzene BiosciencesProliaPhase 3Comparative efficacyCompletedJul 2022Jul 2024NCT05405725

Other developers in the same markets

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

MarketRivalsDevelopers (product)
EMA11Alvotech (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), Teva (Ponlimsi / Degevma), mAbxience (Boncresa / Oziltus / Denbrayce / Izamby)
CDSCO4Hetero (Hetero denosumab), Intas Pharmaceuticals (Osvyrti / Jubereq), Lupin (Lupin denosumab), Reliance Life Sciences (Reliance Life Sciences denosumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Enzene Biosciences: Enzene Biosciences adalimumab, Enzene Biosciences bevacizumab, Enzene Biosciences pertuzumab, Enzene Biosciences ranibizumab, Enzene Biosciences teriparatide.

Chronology

Sources

All denosumab biosimilars

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Data current to September 2026.