Biosimilar vs originator insulins: Systematic review and meta‐analysis
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- Tomohide Yamada
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
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- Ryuichi Kamata
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
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- Kotomi Ishinohachi
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
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- Nobuhiro Shojima
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
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- Sophia Ananiadou
- National Centre for Text Mining, School of Computer Science University of Manchester Manchester UK
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- Hisashi Nom
- Department of Data Science Institute of Statistical Mathematics Tokyo Japan
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- Toshimasa Yamauchi
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
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- Takashi Kadowaki
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine University of Tokyo Tokyo Japan
書誌事項
- 公開日
- 2018-04-17
- 資源種別
- journal article
- 権利情報
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- http://onlinelibrary.wiley.com/termsAndConditions#vor
- DOI
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- 10.1111/dom.13291
- 公開者
- Wiley
この論文をさがす
説明
<jats:p> Biosimilar insulins have expanded the treatment options for diabetes. We compared the clinical efficacy and safety of biosimilar insulins with those of originator insulins by conducting a meta‐analysis. A random‐effects meta‐analysis was performed on randomized controlled trials comparing biosimilar and originator insulins in adults with diabetes. Studies were obtained by searching electronic databases up to December 2017. Ten trials, in a total of 4935 patients, were assessed (2 trials each on LY2963016, MK‐1293, Mylan's insulin glargine and SAR342434, and 1 trial each on FFP‐112 and Basalog). The meta‐analysis found no differences between long‐acting biosimilar and originator insulins with regard to reduction in glycated haemoglobin at 24 weeks (0.04%, 95% confidence interval [CI] –0.01, 0.08; <jats:italic>P</jats:italic> for efficacy = .14, <jats:italic>I</jats:italic> <jats:sup>2</jats:sup> = 0%) or at 52 weeks (0.03%, 95% CI –0.04, 0.1), or reduction in fasting plasma glucose (0.08 mmol/L, 95% CI 0.36, 0.53), hypoglycaemia (odds ratio 0.99, 95% CI 0.96, 1.03), mortality, injection site reactions, insulin antibodies and allergic reactions. Analyses stratified by type of diabetes and prior insulin use yielded similar findings. Similarly, no significant differences were found between short‐acting biosimilar and originator insulins. In summary, our meta‐analysis showed no significant differences in clinical efficacy and safety, including immune reactions, between biosimilar and originator insulins. Biosimilar insulins can increase access to modern insulin therapy and reduce medical costs. </jats:p>
収録刊行物
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- Diabetes, Obesity and Metabolism
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Diabetes, Obesity and Metabolism 20 (7), 1787-1792, 2018-04-17
Wiley
