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Intas etanercept

Etanercept biosimilar developed by Intas Pharmaceuticals. Reference product Enbrel.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Intas Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOSep 2014permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
EtanerceptmoleculeIntas Pharmaceuticalsdeveloper1 of 7markets0trials behind it11other products, same developer3rival developers in its markets

About Intas etanercept

Intas received the first Indian permission for a domestically made etanercept, in September 2014, with a full set of arthritis and psoriasis uses. Cipla's imported product had been permitted two years earlier. Intas's etanercept remains an Indian 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 OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2014
Application or permission
MF-198/2014; BULK-199/2014
Indications as licensed
RA, JIA, PsA, AS, plaque psoriasis
Presentations
25 mg/0.5 mL PFS
Remarks
First domestic etanercept permitted in India.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Intas etanercept holds an approval, these are the other etanercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO3Lupin (Nepexto / Fubelv / Lupin etanercept), Not stated in the CDSCO list (Cipla etanercept), Reliance Life Sciences (Reliance Life Sciences etanercept)

Same developer, other molecules

Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.

Chronology

Sources

All etanercept biosimilars

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Data current to September 2026.