Reliance Life Sciences infliximab
Infliximab biosimilar developed by Reliance Life Sciences. Reference product Remicade.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOMar 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
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2014
Application or permission
MF-61/2014; BULK-62/2014
Indications as licensed
RA, AS, PsA, psoriasis, Crohn's disease, UC
Presentations
100 mg lyophilised vial
Note
First infliximab biosimilar permitted in India.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2014CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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