Cipla etanercept
Etanercept biosimilar developed by Not stated in the CDSCO list. Reference product Enbrel.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Cipla (import)
FDAnot listed
EMAnot listed
CDSCOOct 2012permitted
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
Cipla Limited
Pathway
Import and marketing permission
Approved
Oct 2012
Application or permission
Import permission
Indications as licensed
Rheumatoid arthritis, alone or with methotrexate
Presentations
25 mg lyophilised vial
Note
First etanercept permitted in India.
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2012CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
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