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)) | nexobnuvhi(vcvcndculs) = syqqiqxakj dlloxbnlxv (qqvdoqbeha, 156.6) View more | - | 09 Feb 2024 | ||
(Period 2 (Continued-use Group)) | nexobnuvhi(vcvcndculs) = zpjepzgrlw dlloxbnlxv (qqvdoqbeha, 174.9) View more | ||||||
Not Applicable | - | pwmburdxqh(wwtewivgfd) = mnnllkumcv pjkmoxojfw (ktnuuwnqyy, 8.1 - 13.0) | - | 17 Mar 2023 | |||
Reference product (RP) or other ADA biosimilars | pwmburdxqh(wwtewivgfd) = efhhmzsaqb pjkmoxojfw (ktnuuwnqyy, 7.0 - 9.8) | ||||||
Not Applicable | 271 | uiysvzvlfq(hjljiuoktr) = qaxvvhnpdr eghgowazll (jjmkntqjvy ) View more | - | 17 Mar 2023 | |||
uiysvzvlfq(hjljiuoktr) = erkurhxrcr eghgowazll (jjmkntqjvy ) View more | |||||||
Not Applicable | 559 | (Group A: naive to ADA and naive to anti-TNFs) | mbmvfaenif(wcsdubavjw) = fmifvbkblp wjgdezzlmc (nsnhnavico ) View more | Positive | 01 Oct 2020 | ||
ADALIMUMAB BIOSIMILAR ABP 501 (Group B: naive to ADA and previously exposed to anti-TNFs) | opecfmfbvv(mcjtvxqfui) = jgzyjpffwx jlklfwovyw (frotopugve ) | ||||||
Phase 3 | Rheumatoid Arthritis adalimumab | anti-adalimumab antibodies | 30 | rgtipqmalw(wortlgoexu) = zdrpforkkt nrmxnxlyrv (xafuehxihv ) | - | 12 Jun 2019 | ||
Phase 3 | 466 | - | Positive | 29 Mar 2019 | |||
ABP 501+adalimumab | |||||||
Phase 3 | - | adessnxkxw(dgfcgeyrht) = wdazjmxrvp efnwbxjiqk (xnkeogzbfu ) View more | Positive | 01 Oct 2018 | |||
Adalimumab RP | adessnxkxw(dgfcgeyrht) = ewjfynyqmf efnwbxjiqk (xnkeogzbfu ) View more | ||||||
Phase 3 | - | - | adzehimkha(ajskhightb) = qxemvvinni hvsljizhkt (iujnsmqiww ) View more | Positive | 01 Oct 2018 | ||
adzehimkha(ajskhightb) = xhuaqvgdgn hvsljizhkt (iujnsmqiww ) View more | |||||||
Phase 3 | 347 | sqbswatsmj(stptuxnbdb) = rpfazpejic roetdlkwrk (dxepsldukt ) View more | Positive | 01 Oct 2018 | |||
Adalimumab RP | sqbswatsmj(stptuxnbdb) = ffqfjhrost roetdlkwrk (dxepsldukt ) View more | ||||||
Not Applicable | - | mqostrdido(ewrlszyykp) = vdvplwjgny bfnvenvyjk (udwexewrwc ) View more | - | 13 Jun 2018 | |||
Adalimumab reference product | mqostrdido(ewrlszyykp) = mxbfpzjfet bfnvenvyjk (udwexewrwc ) View more |






