Nepexto / Fubelv / Lupin etanercept
Etanercept biosimilar developed by Lupin, development code YLB113. Reference product Enbrel.
Brands by market: Nepexto and Fubelv (EU); brand not published by CDSCO (India, Lupin and Biocon permissions) · Commercial partner or holder: Biocon Biologics (EU, India; formerly Mylan)
FDAnot listed
EMAMay 2020authorised
CDSCOMar 2019permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Nepexto
European Medicines Agency and European CommissionApprovedBrand
Nepexto
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
May 2020
Application or permission
EMEA/H/C/004711
Indications as licensed
RA, JIA, PsA, axSpA, psoriasis
Presentations
see SmPC
Source
S017
EMA
European Union · Fubelv
European Medicines Agency and European CommissionApprovedBrand
Fubelv
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Apr 2026
Application or permission
EMEA/H/C/006738
Presentations
see SmPC
Note
Second Biocon brand.
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Lupin Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2019
Application or permission
MF/BIO/19/000011; drug substance MF/BIO/BD/19/000011
Indications as licensed
RA, PsA, AS, psoriasis
Presentations
50 mg/mL pen and PFS; 25 mg/0.5 mL PFS
Source
S014
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Mylan Pharmaceuticals Private Limited, now Biocon Biologics Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2021
Application or permission
MF/BIO/21/000005; drug substance Bulk-BIO/03/2021; holder changed to Biocon Biologics under MF/BIO/24/000047 (April 2024)
Indications as licensed
RA, JIA, PsA, AS, psoriasis
Presentations
50 mg/mL and 25 mg/0.5 mL PFS
Note
Marketing authorisation holder changed from Mylan to Biocon Biologics on 30 April 2024.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2019CDSCO permission granted
- EMAMay 2020Authorised by the European Commission as Nepexto
- CDSCOJan 2021CDSCO permission granted
- EMAApr 2026Authorised by the European Commission as Fubelv
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)
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