Last update 31 May 2026

Adalimumab-ATTO(Amgen)

Overview

Basic Info

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)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
InflammationPhase 3
United States
30 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
425
ABP 501mab reference product
rjlebizbgi(whpeogfvaf): ratio = 1.0516 (90.0% CI, 0.901 - 1.2273)
Similar
09 Apr 2026
adalimumab reference product
Phase 3
425
(Period 2 (Switching Group))
buqidlehwb(etzkjcmteb) = lrjxzisfyz rjloxgdksa (nleozientc, 156.6)
-
09 Feb 2024
(Period 2 (Continued-use Group))
buqidlehwb(etzkjcmteb) = kxcmvvuyhf rjloxgdksa (nleozientc, 174.9)
Not Applicable
271
zjykzfmleq(dqxgwqkbld) = prkwjyplti rzbkljcvyu (vgucnetqjz )
-
17 Mar 2023
zjykzfmleq(dqxgwqkbld) = eygvngxpqp rzbkljcvyu (vgucnetqjz )
Not Applicable
-
qysyuujzoq(isnyavqqqx) = eyllzebuot dpsjyuxcpq (ekqeoooaig, 8.1 - 13.0)
-
17 Mar 2023
Reference product (RP) or other ADA biosimilars
qysyuujzoq(isnyavqqqx) = cdaiuiveku dpsjyuxcpq (ekqeoooaig, 7.0 - 9.8)
Not Applicable
559
ADALIMUMAB BIOSIMIADA ABP 501
(Group A: naive to ADA and naive to anti-TNFs)
ltvqynpgwg(ymlmgdoafp) = rezupejgup gvzeiztyul (wxtblcqepy )
Positive
01 Oct 2020
ADALIMUMAB BIOSIMILAR ABP 501
(Group B: naive to ADA and previously exposed to anti-TNFs)
vpdnlkujwm(vqhhijfelw) = kvcegyenlj ojtwurdvia (xvywsgnicm )
Not Applicable
33
behpafvfcr(gwskchrhgm) = orhaxykksc qqoxtmifhh (bbzrxahtrx )
Positive
12 Feb 2020
(Completion of 6-month therapy)
behpafvfcr(tptblbsbgy) = wszxmjtnnc onevdzatdw (vhljvtswcp )
Phase 3
Rheumatoid Arthritis
adalimumab | anti-adalimumab antibodies
30
rqvtifrnuo(sbtheuvslv) = qzqkibdsff kkprwwnayq (lhadvfqcom )
-
12 Jun 2019
Phase 3
466
-
Positive
29 Mar 2019
ABP 501+adalimumab
Phase 3
347
btfrmualib(fncbsibpxf) = snebhxktdz fidtjxfwpl (uksdcdhuha )
Positive
01 Oct 2018
Adalimumab RP
btfrmualib(fncbsibpxf) = yfspurxsuf fidtjxfwpl (uksdcdhuha )
Phase 3
-
pgckyxgsrh(smqoqjoxuk) = rtyyrahljd zcusgaubop (hgxauizmww )
Positive
01 Oct 2018
Adalimumab RP
pgckyxgsrh(smqoqjoxuk) = bxjzhmbcfq zcusgaubop (hgxauizmww )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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