Outcomes of Patients With Inflammatory Bowel Diseases Switched From Maintenance Therapy With a Biosimilar to Remicade

Iliás, Ákos; Szántó, K; Gönczi, Lóránt; Kürti, Zsuzsanna; Golovics, Petra A.; Farkas, Klaudia; Schäfer, Eszter; Szepes, Zoltán; Szalay, Balázs; Vincze, Áron; Szamosi, Tamás; Molnár, Tamás; Lakatos, László

doi:10.1016/j.cgh.2018.12.036

Cited by 27 publications

(25 citation statements)

References 27 publications

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“…As previously described, the act of non-medical switching from an originator product to a biosimilar or vice versa is mandated in multiple jurisdictions in select countries driven by economic reasons [ 6 , 7 , 67 ]. This provides the framework whereby constant fluctuations in pharmaceutical pricing and changes in reimbursement policies can lead to patients being switched multiple times between an originator and the analogous biosimilar (Fig.…”

Section: Multiple Switching Between Originator and A Single Biosimilamentioning

confidence: 99%

“…1 a). This has already happened in the EU, and data from two RW multiple-switch observational studies in clinical settings are available [ 6 , 7 ]. In Hungary, biosimilar infliximab was mandated in 2014 to patients naive to tumor necrosis factor antagonists or those with a ≥ 1-year drug holiday.…”

Section: Multiple Switching Between Originator and A Single Biosimilamentioning

confidence: 99%

“…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 ]. Multiple switching for economic reasons has already occurred in Hungary, Sweden, and Norway [ 6 – 8 ], while in countries such as Australia where automatic substitution of certain biologics is allowed, patients can switch products as often as every month [ 9 , 10 ]. Similar policies may also be introduced in other countries, e.g., in Germany, a new law—the Act for Greater Security in the Pharmaceutical Supply System—went into effect in 2019 and could provide a list of products approved for substitution by 2022, allowing pharmacists to substitute biologics with biosimilars (the framework and conditions for the new law are still being resolved).…”

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: Multiple Switching Between Originator and A Single Biosimilamentioning

confidence: 99%

Section: Multiple Switching Between Originator and A Single Biosimilamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…Beside, evidence of therapeutic efficacy of multiple switching or cross‐switching between biosimilar and originator is lacking. Recent study in real‐life cohort revealed similar efficacy, safety, and formation of antidrug antibodies in patients switching from infliximab biosimilar to the originator . However, the FDA has so far not yet designated any biosimilar as “interchangeable” with currently approved originator.…”

mentioning

confidence: 99%

“…Recent study in real-life cohort revealed similar efficacy, safety, and formation of antidrug antibodies in patients switching from infliximab biosimilar to the originator. 16 However, the FDA has so far not yet designated any biosimilar as "interchangeable" with currently approved originator. There is more work need to be done to show that biosimilar can play an important role in the management of IBD.…”

mentioning

confidence: 99%