Home/Biosimilar Atlas/Etanercept/Erelzi

Erelzi

Etanercept biosimilar developed by Sandoz, development code GP2015. Reference product Enbrel.

Brands by market: Erelzi (USA, EU, UAE) · Commercial partner or holder: Sandoz · Company profile

FDAAug 2016approved

EMAJun 2017authorised

MHRALicenseddate not shown

PMDANot listed

HCApr 2017approved

CDSCONot listed

EDEApr 2020registered

Approved or registered in 5 of 7 markets

Connections

Etanerceptmolecule Sandozdeveloper 5 of 7markets 2trials behind it 9other products, same developer 2rival developers in its markets

About Erelzi

Erelzi is Sandoz's etanercept, the first etanercept biosimilar approved in the United States, in August 2016, though patents have kept it off the American market and will do so until 2029. It was approved in Europe and Canada in 2017 and is registered in the UAE, where it is the only etanercept biosimilar. It comes as a syringe and as the Sensoready pen.

Status by market

FDA

United States · Erelzi

US Food and Drug AdministrationApproved

Brand

Erelzi

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Aug 2016

Application or permission

761042

Licence type

351(k) biosimilar, not interchangeable

Reference product in the Purple Book

Enbrel

Marketing status (Purple Book)

Discontinued

Presentations

25 mg vial, 25 mg/0.5 mL, 50 mg/mL syringe and Sensoready pen

Remarks

First FDA-approved etanercept biosimilar; not launched in the US.

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Erelzi

European Medicines Agency and European CommissionApproved

Brand

Erelzi

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jun 2017

Application or permission

EMEA/H/C/004192

Indications as licensed

RA, JIA, PsA, axSpA, psoriasis

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Erelzi

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Erelzi

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 pen

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Erelzi

Health CanadaApproved

Brand

Erelzi

Holder or applicant

Sandoz Canada Incorporated

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Apr 2017

Application or permission

DIN 02462850, 02462869, 02462877

Presentations

25, 50 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Erelzi

Emirates Drug EstablishmentRegistered

Brand

Erelzi

Holder or applicant

Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store

Pathway

Registered medical product

Registered

Apr 2020

Presentations

25 mg/0.5 mL, 50 mg/mL

Source

S018 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Erelzi by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
GP2015	Sandoz	Enbrel	Phase 3	Comparative efficacy	Completed	Feb 2015	Dec 2016	NCT02638259
GP2015	Sandoz	Enbrel	Phase 3	Comparative efficacy	Completed	Jun 2013	Jun 2014	NCT01891864

Other developers in the same markets

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

Market	Rivals	Developers (product)
FDA	1	Samsung Bioepis (Eticovo / Benepali)
EMA	2	Lupin (Nepexto / Fubelv / Lupin etanercept), Samsung Bioepis (Eticovo / Benepali)
MHRA	2	Lupin (Nepexto / Fubelv / Lupin etanercept), Samsung Bioepis (Eticovo / Benepali)
HC	2	Lupin (Nepexto / Fubelv / Lupin etanercept), Samsung Bioepis (Eticovo / Benepali)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Omnitrope, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.

Chronology

FDAAug 2016Approved by FDA as Erelzi
HCApr 2017Notice of Compliance, Health Canada as Erelzi
EMAJun 2017Authorised by the European Commission as Erelzi
EDEApr 2020Registered in the UAE as Erelzi

Sources

S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)
S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
S018UAE Emirates Drug Establishment, registered medical product directory 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)

All etanercept biosimilars

Planning etanercept biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Data current to September 2026.