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	[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

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]

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]