P445 Prevalence rates of biosimilar discontinuation and switchback to originator biologics following non-medical switching: a meta-analysis of real-world studies

Yifei, L; Skup, Martha; Yang, Min; Chang, Qi; Doctor, Tahera

doi:10.1093/ecco-jcc/jjy222.569

Cited by 1 publication

(2 citation statements)

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“…Those patients for whom the switch fails and who discontinue treatment are sometimes allowed to switch back to the originator product, leading to a multiple-switch scenario. A meta-analysis of 62 RW studies (with almost half of the studies reporting switchback data) showed an annualized (95% confidence interval) switchback rate of 14% (10–17%) among all non-medical switchers and 62% (44–80%) among those who discontinue therapy, suggesting that switchback is occurring in a considerable number of patients who are initially switched from originator to a biosimilar for non-medical reasons [ 4 ]. However, no details were reported on the success of switchback in this analysis.…”

Section: Switchback (Scenario 3)mentioning

confidence: 99%

“…After the initial non-medical switch, changes in pharmaceutical pricing or administrative/reimbursement policies may trigger subsequent switches, leading to a complex multiple-switching environment [ 1 ]. A multiple switch can also occur when the initial non-medical switch from an originator to its biosimilar results in worsening of disease or tolerability issues, at which point the patient may be switched back to the originator for medical reasons [ 4 ]. In many countries, biologics are included as part of tenders and, with physicians unable to opt out, mandated treatment switches are likely to increase; in some cases, switching currently occurs as often as every 4 months [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

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The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

Feagan

Marabani

et al. 2020

Adv Ther

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With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) evidence studies. However, as more biosimilars of the same originator enter the market, multiple switching events between originators and biosimilars is becoming a reality, despite limited evidence to support the efficacy and safety of such practice. Some countries have established guidelines, policies, or laws related to interchangeability and/or automatic substitution, whereas others have left these practices unregulated or controlled by other components of the healthcare system. Collectively, guidelines on single non-medical switching are often vague, with even less focus given to multiple non-medical switching, leaving this practice mostly unregulated. This narrative review will first discuss the current regulatory perspectives on non-medical switching and challenges associated with switching therapies, particularly with the availability of multiple biosimilars. We will then review the current evidence from RCTs and RW studies in the light of three different multiple-switch scenarios currently taking place in clinical practice: switching between an originator and a single biosimilar, switching between biosimilars of the same originator, and the clinical practice of switching back to the originator (i.e., switchbacks) after a failure of the initial non-medical switch to the analogous biosimilar.

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Section: Switchback (Scenario 3)mentioning

confidence: 99%