adalimumab   Click here for help

GtoPdb Ligand ID: 4860

Synonyms: D2E7 [6] | Humira®
Approved drug Immunopharmacology Ligand
adalimumab is an approved drug (FDA (2002), EMA (2003))
Compound class: Antibody
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:
NameTrade nameCompanyClinical PhaseIndicationsReferences
adalimumab-atto; ABP 501 Amjevita; AmgevitaAmgenApproved (2016 FDA, 2017 EMA)As per reference agent[8]
adalimumab-adbm; BI 695501CyltezoBoehringer IngelheimApproved (2017 FDA and EMA)As per reference agent 
ZRC-3197ExemptiaCadila HealthcareApproved (2015 India)Rheumatoid arthritis[2,4]
adalimumab-bwwd; SB5HadlimaSamsung BioepisApproved (2019 FDA)As per originator reference agent 
adalimumab-aacf: MSB11022Idacio; KromeyaFresenius KabiApproved (2019 EMA, 2022 FDA)As per originator reference agent
BCD-057 BiocadPh 3 (NCT02762955)Plaque psoriasis 
adalimumab-adaz; GP2017Hyrimoz; Hefiya; HalimatozSandozApproved (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 PharmaceuticalsPh 3 (NCT02581345)Plaque psoriasis, rheumatoid arthritis  
adalimumab-fkjp; MYL-1401A; FKB327HulioMylan, Fujifilm Kyowa Kirin BiologicsApproved (2018 EMA, 2020 FDA)As per originator reference agent[9,12]
adalimumab-afzb; PF-06410293Abrilada; AmsparityPfizerApproved (2019 FDA, 2020 EMA)As per originator reference agent
adalimumab-aaty; CT-P17YuflymaCelltrion Healthcare Hungary KftApproved (2021 EMA, 2023 FDA)As per originator reference agent
adalimumab-aqvh; CHS-1420Yusimry Coherus BioSciencesApproved (2021 FDA)As per originator reference agent
IBI303 Innovent BiologicsPh 3 (NCT02893254)Active ankylosing spondylitis[1]
adalimumab-ryvk; AVT02Hukyndra; Libmyris; SimlandiAlvotech/DKSH/Stada Arzneimittel/TevaApproved (2021 EMA; 2024 FDA)As per originator reference agent. FDA approved this as an interchangeable biosimilar to Humira.
IUPHAR Pharmacology Education Project (PEP) logo

View more information in the IUPHAR Pharmacology Education Project: adalimumab

References
1. Štefková-Mazochová K, Danda H, Dehaen W, Jurásek B, Šíchová K, Pinterová-Leca N, Mazoch V, Krausová BH, Kysilov B, Smejkalová T et al.. (2022)
Pharmacokinetic, pharmacodynamic, and behavioural studies of deschloroketamine in Wistar rats.
Br J Pharmacol, 179 (1): 65-83. [PMID:34519023]
2. Bandyopadhyay S, Mahajan M, Mehta T, Singh AK, Parikh A, Gupta AK, Kalita P, Patel M, Mendiratta SK. (2015)
Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197.
Biosimilars, 5: 1-18. DOI: 10.2147/BS.S75573
3. Jaffe GJ, Dick AD, Brézin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D et al.. (2016)
Adalimumab in Patients with Active Noninfectious Uveitis.
N Engl J Med, 375 (10): 932-43. [PMID:27602665]
4. Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, Kumar U, Gauri LA, Jadhav P, Bartakke G et al.. (2016)
A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis.
Int J Rheum Dis, 19 (11): 1157-1168. [PMID:26176644]
5. Kawalec P, Mikrut A, Wiśniewska N, Pilc A. (2013)
Tumor necrosis factor-α antibodies (infliximab, adalimumab and certolizumab) in Crohn's disease: systematic review and meta-analysis.
Arch Med Sci, 9 (5): 765-779. [PMID:24273556]
6. Kempeni J. (1999)
Preliminary results of early clinical trials with the fully human anti-TNFalpha monoclonal antibody D2E7.
Ann Rheum Dis, 58 Suppl 1: I70-2. [PMID:10577977]
7. Kronthaler U, Fritsch C, Hainzl O, Seidl A, da Silva A. (2018)
Comparative functional and pharmacological characterization of Sandoz proposed biosimilar adalimumab (GP2017): rationale for extrapolation across indications.
Expert Opin Biol Ther, 18 (8): 921-930. [PMID:29962245]
8. Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. (2017)
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.
Br J Dermatol, 177 (6): 1562-1574. [PMID:28755394]
9. Puri A, Niewiarowski A, Arai Y, Nomura H, Baird M, Dalrymple I, Warrington S, Boyce M. (2017)
Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects.
Br J Clin Pharmacol, 83 (7): 1405-1415. [PMID:28133772]
10. Rau R. (2002)
Adalimumab (a fully human anti-tumour necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials.
Ann Rheum Dis, 61 Suppl 2: ii70-3. [PMID:12379628]
11. Salfeld JG, Allen DJ, Hoogenboom HRJM, Kaymakcalan Z, Labkovsky B, Mankovich JA, McGuinness BT, Roberts AJ, Sakorafas P, Schoenhaut D. (2001)
Human antibodies that bind human TNFα.
Patent number: US6258562. Assignee: Basf Aktiengesellschaft. Priority date: 09/02/1996. Publication date: 10/07/2001.
12. Schreiber S, Yamamoto K, Muniz R, Iwura T. (2020)
Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab.
Pharmacol Res Perspect, 8 (3): e00604. [PMID:32500668]
13. Wollheim FA. (2002)
TNF inhibition as therapy for rheumatoid arthritis.
Expert Opin Investig Drugs, 11 (7): 947-53. [PMID:12084005]