Wezlana / Wezenla
Ustekinumab biosimilar developed by Amgen, development code ABP 654. Reference product Stelara.
Brands by market: Wezlana (USA); Wezenla (EU, UAE) · Commercial partner or holder: Amgen · Company profile
FDAOct 2023approved
EMAJun 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCNov 2024approved
CDSCONot listed
EDEOct 2024registered
Approved or registered in 5 of 7 markets
Connections
About Wezlana / Wezenla
Wezlana is Amgen's ustekinumab, the first ustekinumab biosimilar approved in the United States, in October 2023, and interchangeable from the start. In Europe it is called Wezenla and was approved in 2024, then registered in the UAE later that year and approved in Canada. As with adalimumab, Amgen was first to file and first to launch in the United States.
Status by market
FDA
United States · Wezlana
US Food and Drug AdministrationApprovedBrand
Wezlana
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Oct 2023
Application or permission
761285
Licence type
351(k) interchangeable, designated Oct 2023
Reference product in the Purple Book
Stelara
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV (BLA 761331)
Remarks
First FDA-approved ustekinumab biosimilar; interchangeable on licensure.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Wezenla
European Medicines Agency and European CommissionApprovedBrand
Wezenla
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
Jun 2024
Application or permission
EMEA/H/C/006132
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Wezenla
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Wezenla
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 · Wezlana
Health CanadaApprovedBrand
Wezlana
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Nov 2024
Application or permission
DIN 02553309, 02553317
Presentations
45, 90 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Wezenla
Emirates Drug EstablishmentRegisteredBrand
Wezenla
Holder or applicant
Amgen Technology (Ireland) Unlimited Company · UAE supplier Pharmatrade
Pathway
Registered medical product
Registered
Oct 2024
Presentations
45 mg and 90 mg syringes; 130 mg vial
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Wezlana / Wezenla 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 |
|---|---|---|---|---|---|---|---|---|
| ABP 654 | Amgen | Stelara | Phase 3 | Switching | Completed | Mar 2021 | Feb 2023 | NCT04761627 |
Other developers in the same markets
Where Wezlana / Wezenla holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Bio-Thera Solutions (Starjemza), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| HC | 5 | Alvotech (Selarsdi / Uzpruvo / Usgena), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| EDE | 1 | Dong-A ST (Imuldosa) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Bkemv / Bekemv, Kanjinti, Mvasi, Pavblu, Riabni.
Chronology
- FDAOct 2023Approved by FDA as Wezlana
- EMAJun 2024Authorised by the European Commission as Wezenla
- EDEOct 2024Registered in the UAE as Wezenla
- HCNov 2024Notice of Compliance, Health Canada as Wezlana
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)S018UAE Emirates Drug Establishment, registered medical product directory 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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