Reliance Life Sciences adalimumab
Adalimumab biosimilar developed by Reliance Life Sciences. Reference product Humira.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOJun 2015permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2015
Application or permission
MF-150/2015; BULK-149/2015
Indications as licensed
RA, JIA, PsA, AS and axial SpA, Crohn's disease, UC
Presentations
20 mg and 40 mg PFS (50 mg/mL)
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2015CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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