Alvotech
Biosimilar developer, Iceland. 5 development products across 5 molecules: adalimumab, aflibercept, denosumab, golimumab, ustekinumab.
About Alvotech
Alvotech, based in Iceland, develops biosimilars and licenses every one of them to partners rather than selling itself. Its adalimumab is sold by Teva in the United States and Stada in Europe; its ustekinumab by Teva, Stada and JAMP; its denosumab by Stada and Dr. Reddy's; its aflibercept by Stada and Advanz; and its golimumab, the first approved outside India, by Advanz and Stada. Five molecules are approved in Europe and two in the United States.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Adalimumab | Simlandi / Hukyndra / Libmyris AVT02 | Feb 2024 | Nov 2021 | MHRA | · | Jan 2022 | · | · | 4/7 |
| Aflibercept | Afiveg / Mynzepli AVT06 | · | Aug 2025 | MHRA | · | · | · | · | 2/7 |
| Denosumab | Zvogra / Kefdensis / Xbonzy / Acvybra AVT03 | · | Nov 2025 | MHRA | · | · | · | · | 2/7 |
| Golimumab | Gobivaz / Gotenfia AVT05 | · | Nov 2025 | MHRA | · | · | · | · | 2/7 |
| Ustekinumab | Selarsdi / Uzpruvo / Usgena AVT04 | Apr 2024 | Jan 2024 | MHRA | · | Nov 2023 | · | · | 4/7 |
Month shown is the first approval or registration of that product in that market.
In development
ClinicalTrials.gov lists fourteen comparative trials sponsored by Alvotech for six molecules: adalimumab, aflibercept, denosumab, golimumab, ustekinumab, vedolizumab. Candidates without an approval yet in the seven markets: AVT16, AVT29.
| Molecule | Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|---|
| Adalimumab | AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Feb 2019 | Dec 2019 | Simlandi / Hukyndra / Libmyris | NCT03849404 |
| Adalimumab | AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2020 | May 2021 | Simlandi / Hukyndra / Libmyris | NCT04453137 |
| Adalimumab | AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | Mar 2019 | Feb 2020 | Simlandi / Hukyndra / Libmyris | NCT03849313 |
| Adalimumab | AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | May 2018 | Aug 2018 | Simlandi / Hukyndra / Libmyris | NCT03579823 |
| Aflibercept | AVT29 | Alvotech | Eylea | Phase 3 | Comparative efficacy | Recruiting | Apr 2026 | Jul 2027 | no approval in the seven markets | NCT07489131 |
| Aflibercept | AVT06 | Alvotech | Eylea | Phase 3 | Comparative efficacy | Completed | Jun 2022 | Nov 2023 | Afiveg / Mynzepli | NCT05155293 |
| Denosumab | AVT03 | Alvotech | Prolia | Phase 3 | Comparative efficacy | Completed | Aug 2022 | May 2024 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05395091 |
| Denosumab | AVT03 | Alvotech | Xgeva | Phase 1 | Comparative PK | Completed | Jul 2023 | Apr 2024 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05876949 |
| Denosumab | AVT03 | Alvotech | Prolia | Phase 1 | Comparative PK | Completed | Jun 2022 | Oct 2023 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05126784 |
| Golimumab | AVT05 | Alvotech | Simponi | Phase 1 | Comparative PK | Completed | Dec 2022 | Oct 2023 | Gobivaz / Gotenfia | NCT05632211 |
| Golimumab | AVT05 | Alvotech | Simponi | Phase 3 | Comparative efficacy | Completed | Mar 2023 | Mar 2024 | Gobivaz / Gotenfia | NCT05842213 |
| Ustekinumab | AVT04 | Alvotech | Stelara | Phase 3 | Comparative efficacy | Completed | Jun 2021 | Dec 2021 | Selarsdi / Uzpruvo / Usgena | NCT04930042 |
| Ustekinumab | AVT04 | Alvotech | Stelara | Phase 1 | Comparative PK | Completed | May 2021 | Mar 2022 | Selarsdi / Uzpruvo / Usgena | NCT04744363 |
| Vedolizumab | AVT16 | Alvotech | Entyvio | Phase 3 | Comparative efficacy | Terminated | Sep 2024 | Nov 2025 | no approval in the seven markets | NCT06570772 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.
Companies on the same molecules
Developers whose portfolios overlap most with Alvotech, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.
Chronology
- EMANov 2021Libmyris, adalimumab
- EMANov 2021Hukyndra, adalimumab
- HCJan 2022Simlandi, adalimumab
- HCNov 2023Jamteki, ustekinumab
- EMAJan 2024Uzpruvo, ustekinumab
- FDAFeb 2024Simlandi, adalimumab
- FDAApr 2024Selarsdi, ustekinumab
- EMAAug 2025Afiveg, aflibercept
- EMAAug 2025Mynzepli, aflibercept
- EMANov 2025Acvybra, denosumab
- EMANov 2025Gobivaz, golimumab
- EMANov 2025Kefdensis, denosumab
- EMANov 2025Usgena, ustekinumab
- EMANov 2025Xbonzy, denosumab
- EMANov 2025Zvogra, denosumab
- EMAFeb 2026Gotenfia, golimumab
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