Pyzchiva
Ustekinumab biosimilar developed by Samsung Bioepis, development code SB17. Reference product Stelara.
Brands by market: Pyzchiva (USA, EU); Eksunbi (EU, withdrawn) · Commercial partner or holder: Sandoz (USA, EU)
FDAJun 2024approved
EMAApr 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Pyzchiva
US Food and Drug AdministrationApprovedBrand
Pyzchiva
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Jun 2024
Application or permission
761373
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV (BLA 761425)
Source
S001, S016
EMA
European Union · Pyzchiva
European Medicines Agency and European CommissionApprovedBrand
Pyzchiva
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Apr 2024
Application or permission
EMEA/H/C/006183
Presentations
see SmPC
Source
S017
EMA
European Union · Eksunbi
European Medicines Agency and European CommissionWithdrawnBrand
Eksunbi
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/006448
Withdrawn
Aug 2025
Presentations
see SmPC
Note
Duplicate authorisation.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAApr 2024Authorised by the European Commission as Pyzchiva
- FDAJun 2024Approved by FDA as Pyzchiva
- FDAApr 2025Pyzchiva designated interchangeable
- EMAAug 2025Eksunbi authorisation withdrawn
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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