Anonymous User
Login / Registration

Gastroenterologie
a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2023; 77(1): 34–37. doi: 10.48095/ccgh202334.

On the question of the interchangeability of monoclonal bio­similar antibodies in the treatment of immune-mediated inflammatory diseases

Milan Lukáš1, Ladislav Šenolt2, Spyridon Gkalpakiotis3

+ Affiliation

To read this article in full, please register for free on this website.

Benefits for subscribers

Benefits for logged users

Literature

1. Statement on the scientific rationale supporting interchangeability of bio­similar medicines in the EU. 2022 [online]. Dostupné z: https: //www.ema.europa.eu/en/documents/public-state- ment/statement-scientific-rationale-support- ing-interchangeability-bio­similar-medicines- eu_en.pdf.
2. Lukáš M. Zkušenosti s bio­logickou léčbou v Klinickém centru ISCARE. In: Idiopatické střevní záněty II. Nové trendy a mezioborové zkušenosti. Praha: Grada Publishing 2021; 177–202.
3. Rubbert-Roth A, Szabó MZ, Kedves M et al. Failure of anti-TNF treatment in patients with rheumatoid arthritis: The pros and cons of the early use of alternative bio­logical agents. Autoimmun Rev 2019; 18(12): 102398. doi: 10.1016/ j.autrev.2019.102398.
4. Smolen JS, Landewé RB, Bergstra S et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and bio­logical disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis 2023; 82(1): 3–18. doi: 10.1136/ard-2022-223356.
5. Ramiro S, Nikiphorou E, Sepriano A et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis 2023; 82(1): 19–34. doi: 10.1136/ard-2022-223296.
6. Coates LC, Soriano ER, Corp N et al. GRAPPA Treatment Recommendations domain subcommittees. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol 2022; 18(8): 465–479. doi: 10.1038/s41584-022-00798-0.
7. Nast A, Smith C, Spuls PI et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris – Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venerol 2020; 34(11): 2461–2498. doi: 10.1111/jdv.16915.
8. Lukáš M et al. Pokroky v dia­gnostice a léčbě idiopatických střevních zánětů. Praha: Galén 2019.
9. Lukáš M. Přínos bio­similárních monoklonálních protilátek v terapii idiopatických střevních zánětů. Gastro Hepatol 2022; 76(5): 447–452. doi: 10.48095/ccgh2022447.
10. Fleischmann R, Lakhanpal S, Saikali W et al. Multiple Switching Between the Biosimilar Adalimumab PF-06410293 (Abrilada™) and Reference Adalimumab (Humira®) in Combination with Methotrexate in Patients with Moderately to Severely Active Rheumatoid Arthritis. Arthritis Rheumatol 2022; 74(9).
11. Feldman S, Stroissnig H, Kay R et al. A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Reference Adalimumab (Humira®). Arthritis Rheumatol 2022; 74(9).
12. Ruda RC, Kelly KA, Feldman SR. Real-world outcomes following switching from anti-TNF reference products to bio­similars for the treatment of psoriasis. J Dermatolog Treat 2023; 34(1): 2140569. doi: 10.1080/09546634.2022.2140569.
13. Roccuzzo G, Rozzo G, Burzi L et al. Switching from adalimumab originator to bio­similars in hidradenitis suppurativa: What‘s beyond cost-effectiveness? Dermatol Ther 2022; 35(11): e15803. doi: 10.1111/dth.15803.
14. Jørgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to bio­similar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017; 389(10086): 2304–2316. doi: 10.1016/S0140-6736(17)30068-5.
15. Lukas M, Kolar M, Reisigova J et al. A switch from originator adalimumab to the bio­similar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts. Scand J Gastroenterol. 2022; 57(7): 814–824. doi: 10.1080/00365521.2022.2041082.

Credited self-teaching test