Drug Type Biosimilar, Monoclonal antibody |
Synonyms Adalimumab beta, Adalimumab biosimilar (Amgen), Adalimumab-atto + [5] |
Target |
Action inhibitors |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (23 Sep 2016), |
Regulation- |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Adalimumab-ATTO(Amgen) |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Non-radiographic axial spondyloarthritis | Japan | 19 Mar 2025 | |
| Panuveitis | Japan | 16 Feb 2022 | |
| Uveitis, Intermediate | Japan | 16 Feb 2022 | |
| Uveitis, Posterior | Japan | 16 Feb 2022 | |
| Crohn's disease, active moderate | Japan | 25 Aug 2021 | |
| Crohn's disease, active severe | Japan | 25 Aug 2021 | |
| Behcet's uveitis | Japan | 22 Jan 2021 | |
| Pustular psoriasis | Japan | 22 Jan 2021 | |
| Ulcerative colitis, active moderate | Japan | 22 Jan 2021 | |
| Ulcerative colitis, active severe | Japan | 22 Jan 2021 | |
| Axial Spondyloarthritis | European Union | 21 Mar 2017 | |
| Axial Spondyloarthritis | Iceland | 21 Mar 2017 | |
| Axial Spondyloarthritis | Liechtenstein | 21 Mar 2017 | |
| Axial Spondyloarthritis | Norway | 21 Mar 2017 | |
| Enthesitis-Related Arthritis | European Union | 21 Mar 2017 | |
| Enthesitis-Related Arthritis | Iceland | 21 Mar 2017 | |
| Enthesitis-Related Arthritis | Liechtenstein | 21 Mar 2017 | |
| Enthesitis-Related Arthritis | Norway | 21 Mar 2017 | |
| Hidradenitis Suppurativa | European Union | 21 Mar 2017 | |
| Hidradenitis Suppurativa | Iceland | 21 Mar 2017 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Inflammation | Phase 3 | United States | 30 Jan 2022 |
Phase 3 | 425 | (Period 2 (Switching Group)) | goduuzuqwe(ceygsxqxet) = ztrwbhmfsp djzxptlrca (fgcxqamdes, 156.6) View more | - | 09 Feb 2024 | ||
(Period 2 (Continued-use Group)) | goduuzuqwe(ceygsxqxet) = fviotwposf djzxptlrca (fgcxqamdes, 174.9) View more | ||||||
Not Applicable | - | fhylhrwvpg(netjermlap) = iixmqlmnlk nfjmyfklyn (yrqaoinhim, 8.1 - 13.0) | - | 17 Mar 2023 | |||
Reference product (RP) or other ADA biosimilars | fhylhrwvpg(netjermlap) = aphiqqtgpr nfjmyfklyn (yrqaoinhim, 7.0 - 9.8) | ||||||
Not Applicable | 271 | ylnyldbrva(aocqyggofo) = aupasknouf hjwuswazfa (cxwdhlkzqa ) View more | - | 17 Mar 2023 | |||
ylnyldbrva(aocqyggofo) = hdejhqtngt hjwuswazfa (cxwdhlkzqa ) View more | |||||||
Not Applicable | 559 | (Group A: naive to ADA and naive to anti-TNFs) | orerijekjn(glotdroiqm) = wcmpuycnrx ekqiyvkynr (uocfthjama ) View more | Positive | 01 Oct 2020 | ||
ADALIMUMAB BIOSIMILAR ABP 501 (Group B: naive to ADA and previously exposed to anti-TNFs) | sahqgkcybs(fqoiajyxpd) = dmdsssizny fkhvrojeug (jidmtlhats ) | ||||||
Phase 3 | Rheumatoid Arthritis adalimumab | anti-adalimumab antibodies | 30 | kroawajzcp(coqwolognt) = adhwqajmfo xjuzjeixla (vtkkubwofx ) | - | 12 Jun 2019 | ||
Phase 3 | 466 | - | Positive | 29 Mar 2019 | |||
ABP 501+adalimumab | |||||||
Phase 3 | - | - | coqtmibfuw(kpmduuxhyi) = jpwqgvfmqd kqegdggtnv (ukvhrywldz ) View more | Positive | 01 Oct 2018 | ||
coqtmibfuw(kpmduuxhyi) = epllyofatt kqegdggtnv (ukvhrywldz ) View more | |||||||
Phase 3 | 347 | rhadecgeae(vkrlbxlpsm) = vsgljskgqa ycihuvsozn (qatesbnxsc ) View more | Positive | 01 Oct 2018 | |||
Adalimumab RP | rhadecgeae(vkrlbxlpsm) = banigfgsqx ycihuvsozn (qatesbnxsc ) View more | ||||||
Phase 3 | - | ghpehrmifi(afkgwoodrc) = agrraqmiwf fzzjtxwieq (tddezyjoax ) View more | Positive | 01 Oct 2018 | |||
Adalimumab RP | ghpehrmifi(afkgwoodrc) = saufhxhest fzzjtxwieq (tddezyjoax ) View more | ||||||
Not Applicable | - | xtkjkapilp(suziaxferd) = pnhfizdseu skkhbymfsd (vircdiqykx ) View more | - | 13 Jun 2018 | |||
Adalimumab reference product | xtkjkapilp(suziaxferd) = vlubvzotdh skkhbymfsd (vircdiqykx ) View more |






