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) · Company profile
FDAFeb 2024approved
EMANov 2021authorised
MHRALicenseddate not shown
PMDANot listed
HCJan 2022approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
About Simlandi / Hukyndra / Libmyris
Simlandi is Alvotech's adalimumab, sold in the United States by Teva and in Europe by Stada under two names, Hukyndra and Libmyris. It was the first adalimumab biosimilar in the United States to be approved as interchangeable in the high-concentration form, in February 2024. Alvotech, based in Iceland, licenses its products to partners rather than selling them itself, and JAMP holds the Canadian approval.
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
Reference product in the Purple Book
Humira
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
May 2025
Presentations
20/0.2, 40/0.4, 80/0.8
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Hukyndra
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Hukyndra
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
40 mg pen and syringe; 80 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada · Simlandi
Health CanadaApprovedBrand
Simlandi
Holder or applicant
Jamp Pharma Corporation
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2022
Application or permission
DIN 02523949, 02523957, 02523965
Presentations
40, 80 mg
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 Simlandi / Hukyndra / Libmyris 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 |
|---|---|---|---|---|---|---|---|---|
| AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Feb 2019 | Dec 2019 | NCT03849404 |
| AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2020 | May 2021 | NCT04453137 |
| AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | Mar 2019 | Feb 2020 | NCT03849313 |
| AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | May 2018 | Aug 2018 | NCT03579823 |
Other developers in the same markets
Where Simlandi / Hukyndra / Libmyris holds an approval, these are the other adalimumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 9 | Amgen (Amjevita / Amgevita), Boehringer Ingelheim (Cyltezo), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya) |
| EMA | 7 | Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya) |
| MHRA | 7 | Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya) |
| HC | 7 | Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Alvotech: Afiveg / Mynzepli, Gobivaz / Gotenfia, Selarsdi / Uzpruvo / Usgena, Zvogra / Kefdensis / Xbonzy / Acvybra.
Chronology
- EMANov 2021Authorised by the European Commission as Libmyris
- EMANov 2021Authorised by the European Commission as Hukyndra
- HCJan 2022Notice of Compliance, Health Canada as Simlandi
- 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)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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