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) · Commercial partner or holder: Cipla (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOOct 2012permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Cipla etanercept
Cipla received an Indian import permission for etanercept in October 2012, the first etanercept permitted in India. The regulator's list does not name the manufacturer of the imported product.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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
Remarks
First etanercept permitted in India.
Source
S013 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Cipla etanercept holds an approval, these are the other etanercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 3 | Intas Pharmaceuticals (Intas etanercept), Lupin (Nepexto / Fubelv / Lupin etanercept), Reliance Life Sciences (Reliance Life Sciences etanercept) |
Chronology
- CDSCOOct 2012CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning etanercept biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.