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) · Company profile
FDANot listed
EMAMay 2020authorised
MHRALicenseddate not shown
PMDAMar 2019approved
HCAug 2022approved
CDSCOMar 2019permitted
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Nepexto / Fubelv / Lupin etanercept
Lupin's etanercept was permitted in India in 2019 and has travelled further than any other Indian etanercept. Japan approved it the same year through Yoshindo and Nichi-Iko. Europe approved it in 2020 as Nepexto, first through Mylan and now Biocon Biologics, which added a second European name, Fubelv, in 2026. Canada approved it as Rymti in 2022. In India a second permission, originally Mylan's, passed to Biocon in 2024.
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) · checked Sep 2026
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
Remarks
Second Biocon brand.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Nepexto
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Nepexto
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
25 mg syringe; 50 mg syringe and pen
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Etanercept BS TY / Nichiiko
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Etanercept BS TY / Nichiiko
Holder or applicant
Yoshindo; Nichi-Iko Pharmaceutical
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2019
Indications as licensed
RA, pJIA
Presentations
10 mg, 25 mg and 50 mg syringes; 50 mg pen
Remarks
Etanercept Biosimilar 2.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Rymti
Health CanadaApprovedBrand
Rymti
Holder or applicant
Lupin Pharma Canada Limited
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Aug 2022
Application or permission
DIN 02530295, 02530309
Presentations
50 mg
Source
S022 (Health Canada) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Marketing authorisation holder changed from Mylan to Biocon Biologics on 30 April 2024.
Source
S011 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Nepexto / Fubelv / Lupin etanercept holds an approval, these are the other etanercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 2 | Samsung Bioepis (Eticovo / Benepali), Sandoz (Erelzi) |
| MHRA | 2 | Samsung Bioepis (Eticovo / Benepali), Sandoz (Erelzi) |
| PMDA | 1 | Mochida Pharmaceutical (Etanercept BS MA) |
| HC | 2 | Samsung Bioepis (Eticovo / Benepali), Sandoz (Erelzi) |
| CDSCO | 3 | Intas Pharmaceuticals (Intas 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 Lupin: Armlupeg / Lupin pegfilgrastim, Lupin denosumab, Lupin filgrastim, Lupin insulin glargine, Ranluspec / Vislyfa.
Chronology
- CDSCOMar 2019CDSCO permission granted
- PMDAMar 2019Approved by MHLW as Etanercept BS TY / Nichiiko
- EMAMay 2020Authorised by the European Commission as Nepexto
- CDSCOJan 2021CDSCO permission granted
- HCAug 2022Notice of Compliance, Health Canada as Rymti
- 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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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