Simlandi / Hukyndra / Libmyris
Adalimumab biosimilar developed by Alvotech, development code AVT02. Reference product Humira.
Brands by market: Simlandi (USA); Hukyndra (EU); Libmyris (EU) · Commercial partner or holder: Teva (USA); Stada (EU)
FDAFeb 2024approved
EMANov 2021authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Simlandi
US Food and Drug AdministrationApprovedBrand
Simlandi
Holder or applicant
Alvotech USA Inc.
Pathway
351(k)
Approved
Feb 2024
Application or permission
761299
Licence type
351(k) interchangeable, designated Feb 2024
Presentations
20/0.2, 40/0.4, 80/0.8
Source
S001, S016
EMA
European Union · Libmyris
European Medicines Agency and European CommissionApprovedBrand
Libmyris
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2021
Application or permission
EMEA/H/C/005947
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
EMA
European Union · Hukyndra
European Medicines Agency and European CommissionApprovedBrand
Hukyndra
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2021
Application or permission
EMEA/H/C/005548
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMANov 2021Authorised by the European Commission as Libmyris
- EMANov 2021Authorised by the European Commission as Hukyndra
- FDAFeb 2024Approved by FDA as Simlandi
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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