Path of Interchangeability of Biosimilars in Pediatric Inflammatory Bowel Disease

Patel, Dimple; Park, K.T.

doi:10.1097/mpg.0000000000001572

Cited by 6 publications

(6 citation statements)

References 21 publications

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“…Biosimilars are the highly similar, but not identical, versions of a reference biologic medicine manufactured by a different company (1). Biosimilars have the same clinical therapeutic equivalence, purity, and potency as their reference biologic and can provide the same health benefits at a significantly reduced cost (2,3). Biosimilars have been successfully incorporated into routine care for patients with rheumatic diseases in many countries (4,5).…”

Section: Introductionmentioning

confidence: 99%

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

Gasteiger

Jones

Kleinstäuber

et al. 2020

Arthritis Care & Research

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Objective Patients often hold negative perceptions toward biosimilars that can create barriers to their uptake. Physicians also report uncertainty in how best to explain biosimilars. The aim of this study was to measure the effect of differently framed explanations on patients’ perceptions of and willingness to change to a biosimilar in a hypothetical drug switch. Methods Ninety‐six patients with rheumatic diseases taking an originator biologic were randomized to receive 1 of 4 biosimilar explanations: positive framing with and without an analogy, and negative framing with and without an analogy. Willingness to switch to a biosimilar, perceptions about biosimilars, and the effectiveness of the explanation were measured after the information delivery. Results Positive framing led to more participants being willing to switch (67%) than negative framing (46%). Framing significantly predicted willingness to switch to a biosimilar, with participants in the positive framing group being 2.36 times more willing to switch (P = 0.041). The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046) and thought the explanation was more convincing (P = 0.030). The analogy did not enhance willingness to switch or increase understanding (P > 0.05). Conclusion Positive framing can improve perceptions of and willingness to switch to a biosimilar in patients currently taking biologic treatments.

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Section: Introductionmentioning

confidence: 99%

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

Gasteiger

Jones

Kleinstäuber

et al. 2020

Arthritis Care & Research

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“…43 A recently published article raises concerns over the lack of long-term data on the immunogenicity of biosimilars in pediatric IBD. 38 that the extrapolation of clinical data from adult studies to children with IBD be done with care. As safety data emerged, an updated statement in 2019 suggested that switching from the originator infliximab to CT-P13 is feasible in children with clinical remission, following at least three induction infusions.…”

Section: Adalimumab and Adalimumab Biosimilarmentioning

confidence: 99%

“…Moreover, the biosimilars approved in the USA do not include all the indications for reference drugs, nor are they approved for interchangeability of the products. For example, infliximab is approved for UC as well as CD in adults and children, whereas infliximab biosimilars (Ixifi® and Inflectra®) are not approved for pediatric UC 38 . A switching study is a study (preferably a randomized control trial) that evaluates the effect of switching from the reference drug to a biosimilar and vice versa; an example of which is the NOR‐SWITCH trial (switch from originator infliximab to biosimilar CT‐P13) 39 .…”

Section: Overview Of the Biosimilar Approval Process In The Usamentioning

confidence: 99%

“…The American College of Rheumatology position statement on biosimilars states that safety in adults does not guarantee safety in children 43 . A recently published article raises concerns over the lack of long‐term data on the immunogenicity of biosimilars in pediatric IBD 38 . The authors recommend that the FDA should not assume interchangeability is possible in this patient population until data from long‐term trials are available.…”

Section: Pediatric Ibd and Biosimilarsmentioning

confidence: 99%

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Biosimilars in inflammatory bowel disease

Talathi

Baig

2020

J of Digest Diseases

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The advent of biologics has changed outcomes in many chronic conditions, including inflammatory bowel disease (IBD). Biologics have been used for the induction and remission of ulcerative colitis and Crohn's disease for almost two decades and are effective in patients who used to fail conventional treatment with steroids, immunomodulators. The use of biologics in the treatment of IBD has increased over the last few years, partly due to the rise in its incidence and the use of biologics as a first‐line treatment in severe disease as well as in complicated diseases like penetrating/fistulating Crohn's disease. However, their use is associated with a significant burden to the society with respect to healthcare costs, resulting in the premature discontinuation of therapy in some patients, leading to exacerbations and complications. The introduction of biosimilars a decade ago seems to be a promising approach to reducing the costs related to therapy. Since their introduction, numerous studies conducted in adults and some in children show the efficacy of biosimilars with a similar side‐effect profile to biologics. This review discusses the history of biosimilars in the treatment of IBD, enumerates several such studies and discusses the possibility of using biosimilars in the future.

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“…53 A recent research study expressed worry about the absence of long-term data on the immunogenicity of biosimilars in pediatric IBD. 54 The authors urge that the FDA not presume interchangeability is achievable in this cohort until long-term trial evidence is available. The ESPGHAN Pediatric IBD Porto Group issued its first position statement on the use of biosimilars in pediatric IBD in 2015.…”

mentioning

confidence: 99%

Biosimilars in Pediatric IBD: Updated Considerations for Disease Management

Dipasquale¹,

Cucinotta²,

Romano³

2022

BTT

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Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expired, the development and commercialization of biosimilars through abbreviated licensing pathways represented an affordable alternative in patients fulfilling the indication for biologics. A growing body of evidence, first in adults and then in the pediatric age group too, has provided reassuring data in terms of efficacy and safety of biosimilars both in naïve patients and in those previously on reference drugs who had to switch to the biosimilar. This review summarizes the currently available evidence for biosimilar use in IBD, with a focus on pediatric IBD. The most common practical approaches to biosimilar use in the pediatric clinical settings are also discussed.

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Path of Interchangeability of Biosimilars in Pediatric Inflammatory Bowel Disease

Cited by 6 publications

References 21 publications

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

Biosimilars in inflammatory bowel disease

Biosimilars in Pediatric IBD: Updated Considerations for Disease Management

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