adalimumab   

GtoPdb Ligand ID: 4860

Synonyms: D2E7 [5] | FKB327 | Humira®
adalimumab is an approved drug (FDA (2002), EMA (2003))
Compound class: Antibody
Comment: Adalimumab is an anti-TNFα monoclonal antibody with immunosuppresive activity [5]. It was the first fully human monoclonal antibody drug approved by the FDA.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.

X-ray structures of the apo and TNFα-bound Fab fragment of adalimumab have been deposited to the RCSB Protein Data Bank (IDs 4NYL and 3WD5 respectively).

Biosimilars:
NameTrade nameCompanyClinical PhaseIndicationsReferences
adalimumab-atto; ABP 501 Amjevita; AmgevitaAmgenApproved (2016 FDA, 2017 EMA)As per reference agent[7]
adalimumab-adbm; BI 695501CyltezoBoehringer IngelheimApproved (2017 FDA and EMA)As per reference agent 
ZRC-3197ExemptiaCadila HealthcareApproved (2015 India)Rheumatoid arthritis[1,3]
SB5; adalimumab-bwwdHadlimaSamsung BioepisApproved (2019 FDA)As per reference agent 
MSB11022Idacio; KromeyaFresenius KabiApproved (2019 EMA)As per reference agent
BCD-057 BiocadPh 3 (NCT02762955)Plaque psoriasis 
adalimumab-adaz; GP2017Hyrimoz; Hefiya; HalimatozSandozApproved (2018 EMA and FDA)As per reference agent [6]
M923 Momenta PharmaceuticalsPh 3 (NCT02581345)Plaque psoriasis, rheumatoid arthritis  
MYL-1401AHulioMylanApproved (EMA 2018)As per reference agent 
MSB11022 MerckPh 3 (NCT02660580)Plaque psoriasis, rheumatoid arthritis  
adalimumab-afzb; PF-06410293AbriladaPfizerApproved (2019 FDA)As per reference agent
FKB327 Fujifilm Kyowa Kirin BiologicsPh 3 (NCT02260791)Rheumatoid arthritis[8]
IBI303 Innovent BiologicsPh 3 (NCT02893254)Active ankylosing spondylitis
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View more information in the IUPHAR Pharmacology Education Project: adalimumab

No information available.
Summary of Clinical Use
Used in the management of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis.
In 2015 both the EMA and the FDA approved the use of adalimumab as a treatment for hidradenitis suppurativa, a chronic skin disease that causes abscesses and scarring on the skin.
In July 2016, the FDA expanded adalimumab approval as the first non-corticosteroid drug available for use as a treatment for non-infectious intermediate, posterior and panuveitis (forms of autoimmune-driven inflammation of the uvea)- results from Phase 3 clinical trial NCT01138657 are published in [2]. The EMA marketing authorisation for adalimumab Trudexa® was withdrawn at the request of the marketing authorisation holder.
Mechanism Of Action and Pharmacodynamic Effects
Adalimumab binds to tumor necrosis factor-alpha (TNFα), preventing it from activating TNF receptors. This action downregulates the inflammatory reactions associated with autoimmune diseases. The following references discuss adalimumab's use and action [4,9,11].
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