adalimumab

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Ligands
adalimumab

GtoPdb Ligand ID: 4860

Synonyms: D2E7 [6] | Humira®

adalimumab is an approved drug (FDA (2002), EMA (2003))

Comment: Adalimumab is an anti-TNFα monoclonal antibody with immunosuppresive activity [6]. 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:

Name	Trade name	Company	Clinical Phase	Indications	References
adalimumab-atto; ABP 501	Amjevita; Amgevita	Amgen	Approved (2016 FDA, 2017 EMA)	As per reference agent	[8]
adalimumab-adbm; BI 695501	Cyltezo	Boehringer Ingelheim	Approved (2017 FDA and EMA)	As per reference agent
ZRC-3197	Exemptia	Cadila Healthcare	Approved (2015 India)	Rheumatoid arthritis	[2,4]
adalimumab-bwwd; SB5	Hadlima	Samsung Bioepis	Approved (2019 FDA)	As per originator reference agent
adalimumab-aacf: MSB11022	Idacio; Kromeya	Fresenius Kabi	Approved (2019 EMA, 2022 FDA)	As per originator reference agent
BCD-057		Biocad	Ph 3 (NCT02762955)	Plaque psoriasis
adalimumab-adaz; GP2017	Hyrimoz; Hefiya; Halimatoz	Sandoz	Approved (2018 EMA and FDA)	As per originator reference agent. The FDA approved this as an an interchangeable biosimilar to Humira in 2024.	[7]
M923		Momenta Pharmaceuticals	Ph 3 (NCT02581345)	Plaque psoriasis, rheumatoid arthritis
adalimumab-fkjp; MYL-1401A; FKB327	Hulio	Mylan, Fujifilm Kyowa Kirin Biologics	Approved (2018 EMA, 2020 FDA)	As per originator reference agent	[9,12]
adalimumab-afzb; PF-06410293	Abrilada; Amsparity	Pfizer	Approved (2019 FDA, 2020 EMA)	As per originator reference agent
adalimumab-aaty; CT-P17	Yuflyma	Celltrion Healthcare Hungary Kft	Approved (2021 EMA, 2023 FDA)	As per originator reference agent
adalimumab-aqvh; CHS-1420	Yusimry	Coherus BioSciences	Approved (2021 FDA)	As per originator reference agent
IBI303		Innovent Biologics	Ph 3 (NCT02893254)	Active ankylosing spondylitis	[1]
adalimumab-ryvk; AVT02	Hukyndra; Libmyris; Simlandi	Alvotech/DKSH/Stada Arzneimittel/Teva	Approved (2021 EMA; 2024 FDA)	As per originator reference agent. FDA approved this as an interchangeable biosimilar to Humira.

View more information in the IUPHAR Pharmacology Education Project: adalimumab

No information available.

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 [3]. The EMA marketing authorisation for adalimumab Trudexa® was withdrawn at the request of the marketing authorisation holder.

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 [3]. 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 [5,10,13].

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 [5,10,13].

External links
For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA)

External links

For extended ADME data see the following:

Electronic Medicines Compendium (eMC)
Drugs.com
European Medicines Agency (EMA)