Yesintek / Usrenty
Ustekinumab biosimilar developed by Biocon Biologics, development code Bmab 1200. Reference product Stelara.
Brands by market: Yesintek (USA, EU); Usrenty (EU) · Commercial partner or holder: Biocon Biologics
FDANov 2024approved
EMAFeb 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Yesintek
US Food and Drug AdministrationApprovedBrand
Yesintek
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Nov 2024
Application or permission
761406
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
EMA
European Union · Yesintek
European Medicines Agency and European CommissionApprovedBrand
Yesintek
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/006444
Presentations
see SmPC
Source
S017
EMA
European Union · Usrenty
European Medicines Agency and European CommissionApprovedBrand
Usrenty
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Sep 2025
Application or permission
EMEA/H/C/006794
Presentations
see SmPC
Note
Second Biocon brand.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDANov 2024Approved by FDA as Yesintek
- EMAFeb 2025Authorised by the European Commission as Yesintek
- FDAApr 2025Yesintek designated interchangeable
- EMASep 2025Authorised by the European Commission as Usrenty
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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