Reliance Life Sciences etanercept
Etanercept biosimilar developed by Reliance Life Sciences. Reference product Enbrel.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOMay 2018permitted
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
May 2018
Application or permission
MF-124/2018; BULK-125/2018
Indications as licensed
RA, PsA, AS, psoriasis
Presentations
25 mg lyophilised multi-use vial
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMay 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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