Yuflyma
Adalimumab biosimilar developed by Celltrion, development code CT-P17. Reference product Humira.
Brands by market: Yuflyma (USA, EU) · Commercial partner or holder: Celltrion
FDAMay 2023approved
EMAFeb 2021authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Yuflyma
US Food and Drug AdministrationApprovedBrand
Yuflyma
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
May 2023
Application or permission
761219
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
10/0.1, 20/0.2, 40/0.4, 80/0.8
Source
S001, S016
EMA
European Union · Yuflyma
European Medicines Agency and European CommissionApprovedBrand
Yuflyma
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2021
Application or permission
EMEA/H/C/005188
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAFeb 2021Authorised by the European Commission as Yuflyma
- FDAMay 2023Approved by FDA as Yuflyma
- FDAApr 2025Yuflyma 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)
Planning adalimumab 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.