Therapeutic Effects of Adalimumab Biosimilars on Rheumatoid Arthritis
DOI:
https://doi.org/10.61173/ye92f882Keywords:
Adalimumab, biosimilar, rheumatoid arthritis, pharmacokinetics, clinical trialsAbstract
Rheumatoid arthritis (RA) is a chronic and autoimmune disease. Adalimumab and its generic drugs exerted an effective therapeutic effect on RA. Adalimumab is a monoclonal antibody against CD20. Adalimumab can specifically bind to tumor necrosis factor TNF-α, prevent TNF-α from binding to TNF-α receptors p75 and p55 on the cell surface, and inhibit the biological activity of TNF-α. This article summarizes several generic drugs, including ABP 501, BI 695501, PF-06410293, SB5, FKB327, LBAL, MSB11022, GP2017, etc. The limitation of the study is that it did not evaluate the quality of the research methods as a criterion for inclusion or exclusion in evaluating generic drugs. This article mainly focuses on the generic drugs of Adalimumab, reflecting the differences and similarities between the Adalimumab group and the generic drug group. In addition, the pharmacokinetics, safety, and efficacy of Adalimumab generic drugs were evaluated in several clinical trials. Future research may focus on generating drugs with higher safety, lower costs, and higher efficacy.
References
[1] Di Matteo A, Bathon JM, Emery P. Rheumatoid arthritis. Lancet, 2023; 402(10416): 2019-2033.
[2] Zhao S, Chadwick L, Mysler E, Moots RJ. Review of biosimilar trials and data on adalimumab in rheumatoid arthritis. Current Rheumatology Reports, 2018, 20(10): 57.
[3] Markus R, McBride HJ, Ramchandani M, Chow V, Liu J, Mytych D, Fanjiang G. A review of the totality of evidence supporting the development of the first adalimumab biosimilar ABP 501. Advances in Therapy, 2019, 36(8):1833-1850.
[4] Susan Kirshner, FDA Prescribing Information of Hadlima (SB5), (2022), Available online at: https://www.accessdata.fda. gov/drugsatfda_docs/label/2022/761059Orig1s007lbl.pdf.
[5] Kay J, Cross RK, Feldman SR, Park Y, Hanauer SB. Review of adalimumab biosimilar SB5 in immune-mediated inflammatory diseases. Advances in Therapy, 2024, 41(2): 509- 533.
[6] Menter A, Arenberger P, Balser S, Beissert S, Cauthen A, Czeloth N, Soung J, Jazayeri S, Weisenseel P, Jayadeva G. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Expert Opinion on Biological Therapy, 2021, 21(1): 87-96.
[7] Lu X, Hu R, Peng L, Liu M, Sun Z. Efficacy and safety of adalimumab biosimilars: current critical clinical data in rheumatoid arthritis. Frontiers in Immunology, 2021, 12: 638444.
[8] Genovese MC, Kellner H, Arai Y, Muniz R, Alten R. Longterm safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies. RMD Open, 2020, 6(1): e000987.
[9] Fleischmann RM, Bock AE, Zhang W, Godfrey CM, Vranic I, Cronenberger C, Dokoupilová E. Usability Study of PF- 06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open- Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatology Therapy, 2022, 9(3): 839- 850.
[10] Cai L, Li L, Cheng H, Ding Y, Biao Z, Zhang S, Geng S, Liu Q, Fang H, Song Z, Lu Y, Li S, Guo Q, Tao J, He L, Gu J, Yang Q, Han X, Gao X, Deng D, Li S, Wang Q, Zhu J, Zhang J. Efficacy and safety of hlx03, an adalimumab biosimilar, in patients with moderate-to-severe plaque psoriasis: a randomized, doubleblind, phase III study. Advances in Therapy, 2022, 39(1): 583- 597.
[11] Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. British Journal of Dermatology Supplement, 2020, 182(2): 316- 326.
[12] Vernero M, Bezzio C, Ribaldone DG, Costa S, Scalvini D, Tribocco E, Manes G, Saibeni S. efficacy and safety of adalimumab biosimilar GP2017 in patients with inflammatory bowel disease. Journal of Clinical Medicine, 2023, 12(21): 6839.
Downloads
Published
Issue
Section
License
Copyright (c) 2024 by the authors.

This work is licensed under a Creative Commons Attribution 4.0 International License.
