Denoza
Denosumab biosimilar developed by Apotex. Reference product Prolia and Xgeva.
About Denoza
Denoza is Apotex's denosumab, approved in Canada in March 2026 for both uses. Apotex, Canada's largest generics company, has built a line of biosimilars for its home market that have no counterpart in the United States or Europe, and Denoza is one of them.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada · Denoza
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Denoza holds an approval, these are the other denosumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| HC | 3 | Celltrion (Stoboclo / Osenvelt), Sandoz (Jubbonti / Wyost), Shanghai Henlius Biotech (Bildyos / Bilprevda) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Apotex: Aflivu, Bambevi.
Chronology
- HCMar 2026Notice of Compliance, Health Canada
Sources
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