Similar But Not Identical: Plaque Psoriasis Exacerbation in a Patient With Crohn’s Disease After Switching From CT-P13 to SB2 Infliximab Biosimilar

Pagnini, Cristiano; Paolo, M.C. Di; Angelis, Giulia De; Torcolacci, Federica; Milano, Michele; Trinca, Daniela; Porciello, Roberto; Graziani, Maria Giovanna

doi:10.1093/ibd/izaa128

Cited by 5 publications

(3 citation statements)

References 5 publications

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“…A close examination of this case raises questions about the attribution of PsO exacerbation to the second infliximab biosimilar, because the induction or exacerbation of PsO during anti-TNFα therapy in IBD patients is well known and is already described as a common AE in product labeling. A systematic literature review of such cases based on 222 cases revealed that the mean latency time between initiation of anti-TNFα therapy and onset of the psoriatic lesions was 13.8 months [62], which is close to that observed by Pagnini et al in their case report [61].…”

Section: Case Reportsupporting

confidence: 81%

“…Pagnini and colleagues described an IBD patient who developed PsO after an infliximab biosimilar-to-infliximab biosimilar switch, which then resolved after reverting to the first biosimilar [ 61 ]. A close examination of this case raises questions about the attribution of PsO exacerbation to the second infliximab biosimilar, because the induction or exacerbation of PsO during anti-TNFα therapy in IBD patients is well known and is already described as a common AE in product labeling.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Case Reportsupporting

confidence: 81%

Section: Discussionmentioning

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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“…Overall, the majority of evidence suggests that switching from a reference drug to a biosimilar, or between biosimilars, is not associated with increased immunogenicity, an escalated or clinically meaningful safety risk, or any appreciable loss of effectiveness [136]. Although there exists a single incidental published case of a patient who experienced AEs as a result of cross-switching, this finding is largely discordant with the existing body of evidence [137]. Additional studies of switching between biosimilars other than CT-P13 and SB2 may address remaining clinical concerns by adding to the scientific evidence.…”

Section: Ct-p13 N=24 Patientsmentioning

confidence: 97%

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Mysler¹,

Azevedo

Danese

et al. 2021

Drugs

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Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.

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Infliximab

2020

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Similar But Not Identical: Plaque Psoriasis Exacerbation in a Patient With Crohn’s Disease After Switching From CT-P13 to SB2 Infliximab Biosimilar

Cited by 5 publications

References 5 publications

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

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

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Infliximab

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