Hetero denosumab
Denosumab biosimilar developed by Hetero Biopharma. Reference product Prolia and Xgeva.
About Hetero denosumab
Hetero Biopharma received its denosumab permission in India in December 2024, for the higher dose used in cancer patients rather than the osteoporosis dose. It is the only Indian denosumab permitted first for the cancer use.
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
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Hetero denosumab holds an approval, these are the other denosumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | Enzene Biosciences (Osqay / Enzene 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 Hetero: Hetero bevacizumab, Hetero darbepoetin alfa, Hetero rituximab, Mabura.
Chronology
- CDSCODec 2024CDSCO permission granted
Sources
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