Enzene Biosciences adalimumab
Adalimumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Humira.
About Enzene Biosciences adalimumab
Enzene Biosciences, part of Alkem, received its adalimumab permission in 2022. Its product was the first Indian adalimumab in the high-concentration, citrate-free form, matching the newer version of the originator. Further indications were added in 2024. Enzene has grown quickly into one of the more active Indian biosimilar developers, and its denosumab has reached Europe through Theramex.
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 Enzene Biosciences adalimumab holds an approval, these are the other adalimumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | Hetero (Mabura), Reliance Life Sciences (Reliance Life Sciences adalimumab), Shilpa Biologicals (Shilpa Biologicals adalimumab), Zydus Lifesciences (Exemptia / Cadalimab) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Enzene Biosciences: Enzene Biosciences bevacizumab, Enzene Biosciences pertuzumab, Enzene Biosciences ranibizumab, Enzene Biosciences teriparatide, Osqay / Enzene denosumab.
Chronology
- CDSCOOct 2022CDSCO permission granted
Sources
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