Mabura
Adalimumab biosimilar developed by Hetero Drugs. Reference product Humira.
Brands by market: Mabura (India) · Commercial partner or holder: Hetero Drugs
FDAnot listed
EMAnot listed
CDSCOJul 2017permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India · Mabura
Central Drugs Standard Control OrganisationApprovedBrand
Mabura
Holder or applicant
Hetero Drugs Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jul 2017
Application or permission
MF-124/2017; BULK-125/2017
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, paediatric psoriasis, HS, Crohn's disease, paediatric Crohn's, UC, uveitis
Presentations
10/0.2, 20/0.4, 40/0.8 PFS; 40/0.8 vial (50 mg/mL)
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJul 2017CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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