Last update 29 Aug 2026

Adalimumab biosimilar (Biocon)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Adalimumab Biosimilar (Biocon Ltd.), アダリムマブ, アダリムマブ(遺伝子組換え)
+ [8]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hidradenitis Suppurativa
Australia
14 May 2021
Ankylosing Spondylitis
United States
06 Jul 2020
Arthritis, Psoriatic
United States
06 Jul 2020
Colitis, Ulcerative
United States
06 Jul 2020
Rheumatoid Arthritis
United States
06 Jul 2020
Crohn Disease
European Union
17 Sep 2018
Crohn Disease
Iceland
17 Sep 2018
Crohn Disease
Liechtenstein
17 Sep 2018
Crohn Disease
Norway
17 Sep 2018
Enthesitis-Related Arthritis
European Union
17 Sep 2018
Enthesitis-Related Arthritis
Iceland
17 Sep 2018
Enthesitis-Related Arthritis
Liechtenstein
17 Sep 2018
Enthesitis-Related Arthritis
Norway
17 Sep 2018
Juvenile Idiopathic Arthritis
European Union
17 Sep 2018
Juvenile Idiopathic Arthritis
Iceland
17 Sep 2018
Juvenile Idiopathic Arthritis
Liechtenstein
17 Sep 2018
Juvenile Idiopathic Arthritis
Norway
17 Sep 2018
Non-infectious anterior uveitis
European Union
17 Sep 2018
Non-infectious anterior uveitis
Iceland
17 Sep 2018
Non-infectious anterior uveitis
Liechtenstein
17 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic large plaque psoriasisPhase 3
Bulgaria
01 Jun 2015
Chronic large plaque psoriasisPhase 3
Estonia
01 Jun 2015
Chronic large plaque psoriasisPhase 3
Hungary
01 Jun 2015
Chronic large plaque psoriasisPhase 3
Poland
01 Jun 2015
Chronic large plaque psoriasisPhase 3
Russia
01 Jun 2015
Chronic large plaque psoriasisPhase 3
Ukraine
01 Jun 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
374
(Group 1 :- Humira Continuously)
cbsdvochcp(wllxnauuch) = rlgoewbwrm yjffidkvxg (utvjndgxwf, 1432.80)
-
15 Oct 2024
(Group 2:- Repeated Switches Humira - Hulio)
cbsdvochcp(wllxnauuch) = gkqbiowrar yjffidkvxg (utvjndgxwf, 1636.09)
Phase 3
730
Methotrexate+Adalimumab-FKB-327
xpupelsftj(zdeyhhowsv) = fvvhzhowdg mrlvmmlgxh (yvndbulqef )
Similar
12 Dec 2019
Methotrexate+adalimumab
xpupelsftj(zdeyhhowsv) = hlpxuymjmd mrlvmmlgxh (yvndbulqef )
Phase 3
728
lnyswuawal(fchmylbijq) = lhfxmeuzoc dslkauggsu (pvzajqeydc, 77.1 - 88.3)
Positive
12 Jun 2019
Adalimumab RP
lnyswuawal(fchmylbijq) = jxaqphqmdy dslkauggsu (pvzajqeydc, 74.8 - 90.4)
Phase 3
728
(FKB327)
gtuikvckqr = hvicjoltnh mghasvvcog (yfwldxalhe, shnborcoaf - kfuibthdlp)
-
20 Sep 2017
(Humira®)
gtuikvckqr = jwfvfglkck mghasvvcog (yfwldxalhe, sheensspue - iswqvahhqe)
Phase 3
Rheumatoid Arthritis
C-reactive protein | antidrug antibodies
730
iyydcnqyfe(reiuolllka) = ppgtltxpdu vsuiawtxbe (yblqbgnrqv )
Positive
14 Jun 2017
ADL
iyydcnqyfe(reiuolllka) = rlamroqkvv vsuiawtxbe (yblqbgnrqv )
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Translational Medicine

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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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Accelerate your research with the latest regulatory approval information.

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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