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
FDAOct 2023approved
EMAJun 2024authorised
CDSCOnot listed
EDEOct 2024registered
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
Presentations
45/0.5, 90/1 SC; 130/26 IV (BLA 761331)
Note
First FDA-approved ustekinumab biosimilar; interchangeable on licensure.
Source
S001, S016
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
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
Chronology
- FDAOct 2023Approved by FDA as Wezlana
- EMAJun 2024Authorised by the European Commission as Wezenla
- EDEOct 2024Registered in the UAE as Wezenla
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)
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