Mabura
Adalimumab biosimilar developed by Hetero Drugs. Reference product Humira.
About Mabura
Mabura is Hetero's adalimumab, permitted in India in 2017 with a full set of indications from rheumatoid arthritis to uveitis. It is offered in three strengths as a syringe and in a vial for hospital use. Hetero is one of the larger Indian biosimilar manufacturers and sells Mabura domestically and in some export markets outside the seven regulators covered here.
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 · Mabura
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Mabura holds an approval, these are the other adalimumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | Enzene Biosciences (Enzene Biosciences adalimumab), 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 Hetero: Hetero bevacizumab, Hetero darbepoetin alfa, Hetero denosumab, Hetero rituximab.
Chronology
- CDSCOJul 2017CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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