Switching Among Biosimilars: A Review of Clinical Evidence.
adalimumab
biosimilar
etanercept
infliximab
switch
therapeutic drug monitoring
Journal
Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923
Informations de publication
Date de publication:
2022
2022
Historique:
received:
11
04
2022
accepted:
15
06
2022
entrez:
12
9
2022
pubmed:
13
9
2022
medline:
13
9
2022
Statut:
epublish
Résumé
Biological medicines have improved patients' outcomes, but their high costs may limit access. Biosimilars, alternatives that have demonstrated high similarity in terms of quality, safety, and efficacy to an already licensed originator biological product, could increase competition and decrease prices. Given the expanding number of biosimilars, patients may switch from originator to biosimilar or among biosimilars. Randomized trials and observational studies conducted with multiple biosimilars over many disease areas confirmed the safety and efficacy of switching from originator to biosimilar. This study summarizes evidence on switching between biosimilars for which there are concerns to provide future guidance. A systematic search (MEDLINE, Embase, and Cochrane Library) for studies on anti-TNF agents, assessing clinical efficacy and safety of biosimilar-to-biosimilar switch in chronic inflammatory diseases, was performed. We retrieved 320 records and included 19 clinical studies. One study with historical control compared switching between biosimilars to maintenance of the same biosimilar. Ten were controlled cohort studies comparing switching between two biosimilars vs. switching from originator to a biosimilar or vs. multiple switches. Eight were single-arm cohort studies, where participants switched from one biosimilar to another, and the outcomes were compared before and after the switch. Overall, these studies did not highlight significant concerns in switching between biosimilars. Therefore, switching studies seem difficult to perform and unnecessary with the body of evidence suggesting no real problems in practice coupled with stringent regulatory requirements. Monitoring the use of biosimilars in clinical practice could support clinical decision-making, rational use of biological medicines, and help to further realize possible savings.
Identifiants
pubmed: 36091837
doi: 10.3389/fphar.2022.917814
pii: 917814
pmc: PMC9449694
doi:
Types de publication
Journal Article
Langues
eng
Pagination
917814Informations de copyright
Copyright © 2022 Allocati, Godman, Gobbi, Garattini and Banzi.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
J Crohns Colitis. 2017 Jan;11(1):26-34
pubmed: 27927718
Br J Dermatol. 2018 Sep;179(3):623-631
pubmed: 29917226
Ann Rheum Dis. 2017 Aug;76(8):1426-1431
pubmed: 28473425
JAMA. 2021 Dec 21;326(23):2370-2372
pubmed: 34932096
Ther Drug Monit. 2013 Aug;35(4):530-8
pubmed: 23765033
Aliment Pharmacol Ther. 2021 Apr;53(8):887-899
pubmed: 33647174
Appl Health Econ Health Policy. 2017 Feb;15(1):85-93
pubmed: 27587010
PLoS One. 2017 Dec 28;12(12):e0190147
pubmed: 29284064
Clin Pharmacol Ther. 2020 Oct;108(4):734-755
pubmed: 32236956
Curr Treat Options Gastroenterol. 2019 Mar;17(1):127-145
pubmed: 30680599
Aliment Pharmacol Ther. 2021 Sep;54(5):678-688
pubmed: 34223654
Cost Eff Resour Alloc. 2019 Feb 28;17:5
pubmed: 30867655
Br J Dermatol. 2017 Apr;176(4):928-938
pubmed: 27787890
Dig Liver Dis. 2022 Aug 2;:
pubmed: 35931624
J Comp Eff Res. 2021 Aug;10(12):1019-1052
pubmed: 34241546
Expert Rev Clin Immunol. 2019 Aug;15(8):837-848
pubmed: 31180729
Front Pharmacol. 2019 Nov 29;10:1372
pubmed: 31849647
J Crohns Colitis. 2017 Jan;11(1):3-25
pubmed: 27660341
Br J Dermatol. 2019 Feb;180(2):409-410
pubmed: 30187461
Front Pharmacol. 2021 Jan 08;11:591134
pubmed: 33519450
JAMA Intern Med. 2020 Jun 1;180(6):902-903
pubmed: 32227137
Inflamm Bowel Dis. 2021 Jan 19;27(2):182-189
pubmed: 32083291
Eur J Gastroenterol Hepatol. 2021 Feb 1;32(2):201-207
pubmed: 33369956
Medicine (Baltimore). 2020 Jan;99(2):e18723
pubmed: 31914087
Cells. 2021 Feb 19;10(2):
pubmed: 33669641
J Crohns Colitis. 2018 Nov 15;12(11):1302-1315
pubmed: 30107416
BioDrugs. 2020 Apr;34(2):159-170
pubmed: 31792843
Dig Dis Sci. 2021 Oct;66(10):3548-3554
pubmed: 33037969
BioDrugs. 2022 Jan;36(1):55-69
pubmed: 35133617
Br J Cancer. 2019 Jan;120(2):172-182
pubmed: 30568294
Br J Dermatol. 2020 Aug;183(2):397-398
pubmed: 32133618
RMD Open. 2020 Feb;6(1):
pubmed: 32094304
Eur J Clin Pharmacol. 2018 Apr;74(4):505-511
pubmed: 29247389
Sci Rep. 2021 May 14;11(1):10368
pubmed: 33990652
Rev Esp Enferm Dig. 2021 Nov;113(11):770-775
pubmed: 33486961
Front Pharmacol. 2021 Jun 25;12:625296
pubmed: 34248615
Expert Opin Biol Ther. 2019 Oct;19(10):1097-1105
pubmed: 31387417
Dig Liver Dis. 2019 May;51(5):632-639
pubmed: 30872085
Ann Rheum Dis. 2017 Feb;76(2):346-354
pubmed: 27117698
Adv Ther. 2018 Jun;35(6):749-753
pubmed: 29873005
Therap Adv Gastroenterol. 2021 Jul 20;14:17562848211031420
pubmed: 34349836
Aliment Pharmacol Ther. 2017 May;45(10):1291-1302
pubmed: 28326566
BioDrugs. 2018 Dec;32(6):585-606
pubmed: 30499082
Clin Rheumatol. 2021 Jan;40(1):85-91
pubmed: 32514676
Adv Ther. 2017 Jan;33(12):2160-2172
pubmed: 27798772
Gastroenterology. 2017 Sep;153(3):827-834
pubmed: 28780013
Autoimmun Rev. 2017 Jun;16(6):564-575
pubmed: 28411169
Clin Transl Sci. 2022 Jan;15(1):172-181
pubmed: 34523800
J Gastroenterol. 2017 May;52(5):535-554
pubmed: 28275925
Ther Drug Monit. 2017 Aug;39(4):364-369
pubmed: 28700520
Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606
pubmed: 29692005
Ann Rheum Dis. 2014 Jan;73(1):198-206
pubmed: 23467636
J Clin Med. 2021 Jul 30;10(15):
pubmed: 34362184
Curr Med Res Opin. 2016 May;32(5):829-34
pubmed: 26808864
BioDrugs. 2019 Aug;33(4):357-371
pubmed: 31175632
Sci Rep. 2021 Jul 22;11(1):14976
pubmed: 34294782
JAMA. 2021 Dec 21;326(23):2375-2384
pubmed: 34932077
Drugs. 2021 Nov;81(16):1859-1879
pubmed: 34705255
Lancet. 2017 Jun 10;389(10086):2304-2316
pubmed: 28502609
Ther Drug Monit. 2017 Aug;39(4):327-332
pubmed: 28463887
Clin Exp Immunol. 2018 Jun;192(3):348-365
pubmed: 29431871
J Manag Care Spec Pharm. 2018 Oct;24(10):952-959
pubmed: 30247100
Inflamm Bowel Dis. 2022 Mar 30;28(4):495-501
pubmed: 34013959
Ann Intern Med. 2019 Jan 15;170(2):99-107
pubmed: 30534946
Front Pharmacol. 2019 Mar 28;10:279
pubmed: 30983996
J Intern Med. 2019 Jun;285(6):653-669
pubmed: 30762274
Gastroenterology. 2019 Jun;156(8):2349-2351
pubmed: 31034829
Hosp Pract (1995). 2021 Oct;49(4):266-272
pubmed: 33734004
Syst Rev. 2018 Nov 14;7(1):191
pubmed: 30428932
BioDrugs. 2021 Jul;35(4):469-471
pubmed: 33974243
Clin Rheumatol. 2017 Jan;36(1):25-34
pubmed: 27726046
Ann Rheum Dis. 2017 Feb;76(2):355-363
pubmed: 27130908
Expert Rev Pharmacoecon Outcomes Res. 2015;15(5):755-8
pubmed: 26368060
Lancet. 2018 Sep 1;392(10149):791-794
pubmed: 30037734
Scand J Gastroenterol. 2018 Jun;53(6):700-707
pubmed: 29687730
Semin Arthritis Rheum. 2020 Dec;50(6):1449-1456
pubmed: 32268935
Gastroenterology. 2021 Jun;160(7):2340-2353
pubmed: 33676969
Expert Rev Pharmacoecon Outcomes Res. 2021 Aug;21(4):527-540
pubmed: 33535841
Ann Rheum Dis. 2014 Mar;73(3):516-28
pubmed: 24399231
Lancet. 2019 Apr 27;393(10182):1699-1707
pubmed: 30929895