TY - JOUR
T1 - Biosimilar vs originator insulins: Systematic review and meta-analysis
AU - Yamada, Tomohide
AU - Kamata, Ryuichi
AU - Ishinohachi, Kotomi
AU - Shojima, Nobuhiro
AU - Ananiadou, Sophia
AU - Nom, Hisashi
AU - Yamauchi, Toshimasa
AU - Kadowaki, Takashi
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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; P for efficacy = .14, I2 = 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.
AB - 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; P for efficacy = .14, I2 = 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.
U2 - 10.1111/dom.13291
DO - 10.1111/dom.13291
M3 - Article
SN - 1462-8902
VL - 20
SP - 1787
EP - 1792
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 7
ER -