Exemptia / Cadalimab
Adalimumab biosimilar developed by Cadila Healthcare (Zydus Lifesciences), development code ZRC-3197. Reference product Humira.
Brands by market: Exemptia (India); Cadalimab (India, second brand); Adfrar (India, Torrent) · Commercial partner or holder: Zydus Lifesciences; Torrent (Adfrar)
FDAnot listed
EMAnot listed
CDSCOSep 2014permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India · Exemptia
Central Drugs Standard Control OrganisationApprovedBrand
Exemptia
Holder or applicant
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2014
Application or permission
MF-222/2014; BULK-223/2014
Indications as licensed
Rheumatoid arthritis (adult) at permission
Presentations
20 mg and 40 mg PFS (50 mg/mL)
Note
First adalimumab biosimilar approved anywhere.
Source
S014
CDSCO
India · Adfrar
Central Drugs Standard Control OrganisationUnverifiedBrand
Adfrar
Holder or applicant
Torrent Pharmaceuticals
Pathway
Marketed brand
Approved
Unverified
Presentations
20 mg and 40 mg PFS (50 mg/mL)
Source
S006, S014
Marketed brand; no separate CDSCO permission appears in the published lists.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2014CDSCO permission granted as Exemptia
- CDSCODec 2014Exemptia launched by Zydus Cadila
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S006GaBI Online, Biosimilars of adalimumab Secondary
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