Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health

Braun, Jürgen; Kudrin, Alex

doi:10.1016/j.biologicals.2016.03.006

Cited by 78 publications

(48 citation statements)

References 63 publications

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“…Two months later, a review entitled "Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health" published in Biologicals journal concluded that whilst prudent switching practices should be employed, growing safety experience accumulated thus far with infliximab CT-P13 and other biosimilars was favourable and did not raise any specific concerns [21]. Similar evidence that was in favour of switching had also started to surface [19,22].…”

Section: Methodsmentioning

confidence: 99%

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

O’Brien¹,

Carrol²,

Mulcahy³

et al. 2018

GaBI J

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Section: Methodsmentioning

confidence: 99%

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

O’Brien¹,

Carrol²,

Mulcahy³

et al. 2018

GaBI J

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“…Several manufacturers, as well as other stakeholders, have initiated switching studies [28]. An overview is also given by Braun et al [29]. The new and updated positions of the Regulatory Agencies of Finland, Germany and The Netherlands refl ect the increasing number of available biosimilars and the need of fi rst assessments through the national regulatory bodies.…”

Section: Original Researchmentioning

confidence: 99%

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Reiland¹,

Freischem²,

Roediger³

2017

GaBI J

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Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the fi rst biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off -patent biologicals. Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas. Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specifi c policies for off -patent biologicals in place and therefore take account of the specifi cities of biologicals. Nevertheless, variations exist and refl ect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the fi rst EBE survey, shifts have been seen in the areas of substitution and interchangeability. Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place that refl ect the diff erent nature of biological medicines. However, policies and their implementation vary among diff erent jurisdictions.

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“…This study has several limitations such as the small sample size, the heterogeneity of time of switching during therapy, and the great variation in length of the individual follow-up period, but it demonstrates that switching from IFX to CT-P13 seems to be well tolerated in children with CD (Table 2). 60,63–65…”

Section: Switching and Alternation Of Biosimilarsmentioning

confidence: 99%

CT-P13: design, development, and place in therapy

Gabbani

Deiana

Annese³

2017

DDDT

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The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.

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Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health

Cited by 78 publications

References 63 publications

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

CT-P13: design, development, and place in therapy

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