610 Both Single and Multiple Switching Between Infliximab Biosimilars Can Be Safe and Effective in Inflammatory Bowel Disease (Ibd): Real World Outcomes From the Edinburgh Ibd Unit

Siakavellas, Spyros I.; Barrett, Rachael A.; Plevris, Nikolas; Derikx, Lauranne; Gauci, Julia; Lucaciu, Laura; Watson, Eleanor; Arnott, I.; Noble, Colin; Jones, Gareth; Lees, Charlie W.

doi:10.1016/s0016-5085(21)01042-8

Cited by 5 publications

(3 citation statements)

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“…Ten controlled cohort studies compared switching between two biosimilars vs. switching from originator to a biosimilar or vs. multiple switches, for example, from an originator to biosimilar A to biosimilar B ( Lauret et al, 2020 ; Gall et al, 2021 ; Hanzel et al, 2021 ; Khan et al, 2021 ; Lovero et al, 2021 ; Luber et al, 2021 ; Macaluso et al, 2021 ; Trystram et al, 2021 ; Lontai et al, 2022 ; Mazza et al, 2022 ). Eight were single-arm cohort studies, where participants switched from one biosimilar to another and outcome were compared before and after the switch ( Bouhnik et al, 2020 ; Gisondi et al, 2020 ; Kiltz et al, 2020 ; Mott et al, 2021 ; Peters et al, 2021 ; Piaserico et al, 2021 ; Ribaldone et al, 2021 ; Siakavellas et al, 2021 ).…”

Section: Methodsmentioning

confidence: 99%

Switching Among Biosimilars: A Review of Clinical Evidence

et al. 2022

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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.

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Section: Methodsmentioning

confidence: 99%

Switching Among Biosimilars: A Review of Clinical Evidence

et al. 2022

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“…Furthermore, in another study with a follow-up period of < 1 year (8 months, safety events in single-switch (n = 43; CT-P13 to SB2) and double-switch (n = 24, infliximab reference biologic to CT-P13 to SB2) groups did not differ from those of the reference-to-biologic switch group [35]. Similarly, a single-center study in the Edinburgh IBD unit examined IBD patients (n = 246) who were switched from CT-P13 to GP1111 (57/246, double-switch) [36]. No significant differences were observed between the Harvey-Bradshaw Index, Mayo Score, CRP, fecal calprotectin, and trough infliximab levels comparing before and 6 months after GP1111 switch in either CT-P13 to GP1111 (single biosimilar-to-biosimilar switch) or infliximab reference to CT-P13 to GP1111 groups (double switch) [36].…”

Section: Studies In Patients With Inflammatory Bowel Diseasementioning

confidence: 99%

“…Similarly, a single-center study in the Edinburgh IBD unit examined IBD patients (n = 246) who were switched from CT-P13 to GP1111 (57/246, double-switch) [36]. No significant differences were observed between the Harvey-Bradshaw Index, Mayo Score, CRP, fecal calprotectin, and trough infliximab levels comparing before and 6 months after GP1111 switch in either CT-P13 to GP1111 (single biosimilar-to-biosimilar switch) or infliximab reference to CT-P13 to GP1111 groups (double switch) [36].…”

Section: Studies In Patients With Inflammatory Bowel Diseasementioning

confidence: 99%

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies

et al. 2022

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Background Multiple switches (transitions) between biosimilars of the same reference biologic are now a reality, and they are expected to become more common in the future as more biosimilars enter the market. Switching between two biosimilars of the same reference biologic is generally driven by affordability, formulary requirements, or the relocation/travel of the patient. Evidence of whether switching between biosimilars of the same reference biologic provides similar safety and efficacy profiles is reviewed here. Methods A systematic search was undertaken using electronic databases (to December 2021): Biosis, Embase, MEDLINE, and EBM Reviews/Cochrane Database of Systematic Reviews via Ovid. Publications were evaluated for effectiveness and/ or safety data linked to switching from one biosimilar to another. ResultsThe systematic search yielded 982 citations. After eliminating duplicates, 626 citations remained for the initial title/ abstract screening phase. Following the initial screening, 240 records were chosen; more thorough examination yielded 35 citations. After comprehensive screening and expert advice, 23 studies were selected, of which 13 were published in peerreviewed journals; the remainder have been published as abstracts. Overall, 3657 patients were included in these studies. All studies were observational in nature; no randomized clinical trials were identified. The studies were heterogeneous in size, design, and endpoints. Across the studies, data are provided on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns. The majority of studies examined switches between biosimilar infliximabs, although switches between biosimilar adalimumabs, etanercepts, and rituximabs were also identified. Two use-pattern studies and one case report were also detected and are discussed. Conclusion Within the limitations of this systematic review, available data suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice, although it is not covered by current health authority regulations or guidance. No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date.

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Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

Cohen,

Bodenmueller

2024

BioDrugs

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As of 31 December, 2023, 31 observational studies have been published, including a total of 6081 patients who underwent a switch from one biosimilar to another biosimilar of the same reference biologic. Most studies evaluated infliximab, while a smaller number evaluated adalimumab, rituximab or etanercept. Indications studied now include sarcoidosis, as well as the indications previously reported of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis and inflammatory bowel disease (Crohn’s disease and ulcerative colitis). This updated data set includes eight additional studies and 2386 more patients compared with those included in an earlier systematic review of biosimilar-to-biosimilar switching. In addition, since the earlier systematic review was published in 2022, the European Medicines Agency has stated that reference-to-biosimilar and biosimilar-to-biosimilar switching in the European Union is safe and efficacy remains unchanged after switching. Furthermore, following a review of the available evidence, the US Food and Drug Administration has confirmed that initial safety and immunogenicity concerns related to biosimilar switching are unfounded and that no differences are observed in efficacy, safety or immunogenicity following one or more switches. The availability of this new efficacy and safety data together with the supportive statements from the European Medicines Agency and the Food and Drug Administration re-confirm the conclusion that as a scientific matter, biosimilar-to-biosimilar switching is an effective clinical practice, with no new safety concerns. Any suggestions to the contrary are not supported by the evidence.

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610 Both Single and Multiple Switching Between Infliximab Biosimilars Can Be Safe and Effective in Inflammatory Bowel Disease (Ibd): Real World Outcomes From the Edinburgh Ibd Unit

Cited by 5 publications

References 0 publications

Switching Among Biosimilars: A Review of Clinical Evidence

Switching Among Biosimilars: A Review of Clinical Evidence

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

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