Biocad infliximab
Infliximab biosimilar developed by Biocad, development code BCD-055. Reference product Remicade.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Biocad India (import)
FDAnot listed
EMAnot listed
CDSCODec 2019permitted
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
Biocad India Pvt Ltd
Pathway
Import and marketing permission
Approved
Dec 2019
Application or permission
Import permission
Indications as licensed
RA, PsA, AS, psoriasis, Crohn's disease, UC
Presentations
100 mg lyophilised vial
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCODec 2019CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning infliximab biosimilar development?
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