Cyltezo
Adalimumab biosimilar developed by Boehringer Ingelheim, development code BI 695501. Reference product Humira.
Brands by market: Cyltezo (USA); Cyltezo (EU, withdrawn) · Commercial partner or holder: Boehringer Ingelheim
FDAAug 2017approved
EMAwithdrawn
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Cyltezo
US Food and Drug AdministrationApprovedBrand
Cyltezo
Holder or applicant
Boehringer Ingelheim Pharmaceuticals, Inc.
Pathway
351(k)
Approved
Aug 2017
Application or permission
761058
Licence type
351(k) interchangeable, designated Oct 2021
Presentations
10/0.2, 20/0.4, 40/0.4, 40/0.8
Note
First interchangeable adalimumab biosimilar.
Source
S001, S016
EMA
European Union · Cyltezo
European Medicines Agency and European CommissionWithdrawnBrand
Cyltezo
Holder or applicant
Boehringer Ingelheim International GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2017
Application or permission
EMEA/H/C/004319
Withdrawn
Jan 2019
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAAug 2017Approved by FDA as Cyltezo
- EMAJan 2019Cyltezo authorisation withdrawn
- FDAOct 2021Cyltezo designated interchangeable
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)
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