2020
DOI: 10.1186/s12961-020-00611-y
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Health technology assessment of biosimilars worldwide: a scoping review

Abstract: Background: Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and me… Show more

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Cited by 11 publications
(13 citation statements)
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“…This is an excellent indicator of the comprehensiveness of assessments being published. Although, this is in contrast to previously done reviews on HTAs for other medical fields such as the review by Ascef et al (21), wherein rapid reviews were the most common type. It is due to the increasing demand and need for faster HTA generation (20).…”
Section: Discussioncontrasting
confidence: 75%
“…This is an excellent indicator of the comprehensiveness of assessments being published. Although, this is in contrast to previously done reviews on HTAs for other medical fields such as the review by Ascef et al (21), wherein rapid reviews were the most common type. It is due to the increasing demand and need for faster HTA generation (20).…”
Section: Discussioncontrasting
confidence: 75%
“…Thus, trust in the rigour of the existing EMA biosimilar approval system to support substitution is the only thing that remains to be communicated by regulators, although the publication by Kurki et al, 2021 [ 38 ] is a step on the way. Ultimately, the implementation of substitution depends on political incentives for member states as well as their health technology assessment (HTA) bodies’ reviews [ 40 ].…”
Section: Discussionmentioning
confidence: 99%
“…For this, these drugs are identified with a black symbol (inverted triangle) with corresponding text in the SmPC and IF. With this new approach, the strengthening of the PV of all medicines has been seen, increasing the transparency, communication, and trust [ 55 , 56 ].…”
Section: Post-marketing Monitoring Of Safety Of Biosimilars—pharmacov...mentioning
confidence: 99%
“…Despite the numerous benefits that biosimilars bring, there exist notable disparities in their utilization, namely cost savings and market shares. These disparities pose significant questions regarding the safety, efficacy, and interchangeability of these drugs [ 56 , 57 ].…”
Section: Controversies In the Use Of Biosimilarsmentioning
confidence: 99%