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Brands by market: Pyzchiva (USA, EU); Eksunbi (EU, withdrawn) · Commercial partner or holder: Sandoz (USA, EU) · Company profile
FDAJun 2024approved
EMAApr 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCAug 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
About Pyzchiva
Pyzchiva is Samsung Bioepis's ustekinumab, sold by Sandoz in the United States and Europe. It was approved in Europe in April 2024, in the United States in June and in Canada in August, and is interchangeable in the United States. A duplicate European name, Eksunbi, was withdrawn in 2025.
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
Reference product in the Purple Book
Stelara
Marketing status (Purple Book)
Prescription, marketed
Presentations
45/0.5, 90/1 SC; 130/26 IV (BLA 761425)
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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Withdrawn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
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Pyzchiva
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Pyzchiva
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
45 mg and 90 mg syringes and pens; 130 mg vial
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada · Pyzchiva
Health CanadaApprovedBrand
Pyzchiva
Holder or applicant
Samsung Bioepis CO., LTD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Aug 2024
Application or permission
DIN 02550539, 02550547, 02550520
Presentations
45, 90 mg; 5 mg
Remarks
Also Pyzchiva I.V..
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Pyzchiva by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| SB17 | Samsung Bioepis | Stelara | Phase 1 | Comparative PK | Completed | Feb 2021 | Apr 2022 | NCT04772274 |
| SB17 | Samsung Bioepis | Stelara | Phase 3 | Comparative efficacy | Completed | Jul 2021 | Feb 2022 | NCT04967508 |
Other developers in the same markets
Where Pyzchiva holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Bio-Thera Solutions (Starjemza), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina) |
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro) |
| HC | 5 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Renflexis / Flixabi.
Chronology
- EMAApr 2024Authorised by the European Commission as Pyzchiva
- FDAJun 2024Approved by FDA as Pyzchiva
- HCAug 2024Notice of Compliance, Health Canada 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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