Intas etanercept
Etanercept biosimilar developed by Intas Pharmaceuticals. Reference product Enbrel.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Intas Pharmaceuticals
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
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2014
Application or permission
MF-198/2014; BULK-199/2014
Indications as licensed
RA, JIA, PsA, AS, plaque psoriasis
Presentations
25 mg/0.5 mL PFS
Note
First domestic etanercept permitted in India.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2014CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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