Erelzi
Etanercept biosimilar developed by Sandoz, development code GP2015. Reference product Enbrel.
Brands by market: Erelzi (USA, EU, UAE) · Commercial partner or holder: Sandoz
FDAAug 2016approved
EMAJun 2017authorised
CDSCOnot listed
EDEApr 2020registered
Status by market
FDA
United States · Erelzi
US Food and Drug AdministrationApprovedBrand
Erelzi
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Aug 2016
Application or permission
761042
Licence type
351(k) biosimilar, not interchangeable
Presentations
25 mg vial, 25 mg/0.5 mL, 50 mg/mL syringe and Sensoready pen
Note
First FDA-approved etanercept biosimilar; not launched in the US.
Source
S001, S016
EMA
European Union · Erelzi
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Erelzi
Emirates Drug EstablishmentRegisteredBrand
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
Chronology
- FDAAug 2016Approved by FDA 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)
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.
Talk to a biosimilar regulatory consultantData current to September 2026.