Last update 22 Oct 2025

Adalimumab biosimilar (Merck Serono Sa)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Adalimumab Biosimilar (mAbxience SA), Adalimumab Biosimilar (Merck Serono SA), adalimumab(Merck Serono SA)
+ [5]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D02597--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyarticular Juvenile Idiopathic Arthritis
United States
13 Dec 2022
Axial Spondyloarthritis
European Union
02 Apr 2019
Axial Spondyloarthritis
Iceland
02 Apr 2019
Axial Spondyloarthritis
Liechtenstein
02 Apr 2019
Axial Spondyloarthritis
Norway
02 Apr 2019
Crohn's disease, active moderate
European Union
02 Apr 2019
Crohn's disease, active moderate
Iceland
02 Apr 2019
Crohn's disease, active moderate
Liechtenstein
02 Apr 2019
Crohn's disease, active moderate
Norway
02 Apr 2019
Crohn's disease, active severe
European Union
02 Apr 2019
Crohn's disease, active severe
Iceland
02 Apr 2019
Crohn's disease, active severe
Liechtenstein
02 Apr 2019
Crohn's disease, active severe
Norway
02 Apr 2019
Enthesitis-Related Arthritis
European Union
02 Apr 2019
Enthesitis-Related Arthritis
Iceland
02 Apr 2019
Enthesitis-Related Arthritis
Liechtenstein
02 Apr 2019
Enthesitis-Related Arthritis
Norway
02 Apr 2019
Juvenile Idiopathic Arthritis
European Union
02 Apr 2019
Juvenile Idiopathic Arthritis
Iceland
02 Apr 2019
Juvenile Idiopathic Arthritis
Liechtenstein
02 Apr 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-infectious posterior uveitisPhase 1
United States
15 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
2,049
(Patients with rheumatoid arthritis (RA))
iyjxsgijuf(dkcfdrwwcj) = kcrohnfbqi bbbqhxqvpr (ckpehybubq )
Positive
31 May 2023
(Patients with psoriatic arthritis (PsA))
iyjxsgijuf(dkcfdrwwcj) = nchikwuhfq bbbqhxqvpr (ckpehybubq )
Phase 3
288
vxzwwvaiib(jniecsflii) = jpbvlxtikv yodchktfza (otmrajavos, 1.56 - 8.91)
Similar
01 Dec 2019
vxzwwvaiib(jniecsflii) = gcmjrvjnga yodchktfza (otmrajavos, 2.41 - 10.58)
Phase 3
288
btzpeyhdyo(pqiubcshry) = uulveetjgb wrghprunqb (pqnqeqobpg )
Positive
12 Jun 2019
btzpeyhdyo(pqiubcshry) = vbzdxptfcy wrghprunqb (pqnqeqobpg )
Phase 3
288
(MSB11022)
jnvqwkgxwn = ldqdivghrs tlcrwdskhi (zibhnflvvy, gwxexxiuzo - jbasdslrik)
-
23 Apr 2019
EU-Humira
(EU-Humira)
jnvqwkgxwn = twljndmfho tlcrwdskhi (zibhnflvvy, dqhdhfaqpz - qbxjxqisjt)
Phase 3
443
(MSB11022 (Core Treatment Period))
qmidzaaugc = nphjcnyepo aahnszqyyl (kpzrzqotjd, nfynqkfwjt - mtgmjbafaq)
-
19 Feb 2019
(EU-Humira)
qmidzaaugc = eedgfdwizi aahnszqyyl (kpzrzqotjd, mhicoztgsd - pexqokjnpz)
Phase 3
443
weijjbiqlv(mewxdbdhqz) = njxqyyyxdk jjumssgkoa (tlvqalsgfp )
Positive
13 Jun 2018
Adalimumab originator
weijjbiqlv(mewxdbdhqz) = gruwhmlxpk jjumssgkoa (tlvqalsgfp )
Phase 1
-
213
ilunznaoai(iufdelketj) = hqvddwqhsm zdspkeortx (ijftuhfgkm )
-
01 Oct 2016
Not Applicable
-
Adalimumab 40mg every other week
jjpcvottkf(rhgbukqdek) = ryvifqdexl ppiepnkviu (zmwzxtljdv )
-
01 Oct 2015
Adalimumab 40mg every week
vozojpfxph(hmcexchfvf) = viudjtpktb hxtbnfnyfx (lwiulbhavu )
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Deal

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Core Patent

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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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