SB5 (Samsung US and EU Randomised, Healthy 90% CI for the ratio Twelve subjects [1] Bioepis Co Ltd) Humira 40mg single-blind, volunteers of treatment were ADA positive single dose, (n=189) means for area at baseline (n=5 SB5; three arm, under the n=2 EU Humira; n=5 parallel group concentration-time US Humira). ADA study (1:1:1) curve from time were detected in zero to the last 185/189 subjects quantifiable after treatment concentration administration, with (AUClast), 68.3%, 73.0% and 65.1% of patients in from time zero the SB5, EU Humira extrapolated to and US Humira infinite time groups, respectively, (AUCinf) and exhibiting positive maximal plasma ADAs on Day 15 and concentration 96.8%, 93.7% and (Cmax) were within 98.4% of patients in the pre-specified the SB5, EU Humira limits of 80-125% and US Humira for the groups, respectively, comparisons of SB5 exhibiting positive with US Humira ADAs on Day 71. The and SB5 with EU incidence of ADA Humira, as well as development was for US and EU not significantly Humira. different between the treatments. Bevacizumab BI695502 US and EU Randomised, Healthy male 90% CI for the ratio Not reported. [2] (Boehringer Avastin single-blind, volunteers of treatment Ingelheim) 1mg/kg single dose, (n=90) means for area three-arm, under the parallel group concentration-time study (1:1:1) curve from time zero to the last quantifiable concentration (AUC0-tz), from time zero extrapolated to infinite time (AUC0-∞) and maximal plasma concentration (Cmax) were within the pre-specified limits of 80-125% for the comparisons of BI695502 with US Avastin and BI695502 with EU Avastin, as well as for US and EU Avastin.
SB5 (Samsung Bioepis Co Ltd) US and EU Humira 40mg Randomised, single-blind, single dose, three arm, parallel group study (1:1:1) Healthy volunteers (n=189) 90% CI for the ratio of treatment means for area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast), from time zero extrapolated to infinite time (AUCinf) and maximal plasma concentration (Cmax) were within the pre-specified limits of 80-125% for the comparisons of SB5 with US Humira and SB5 with EU Humira, as well as for US and EU Humira. Twelve subjects were ADA positive at baseline (n=5 SB5; n=2 EU Humira; n=5 US Humira). ADA were detected in 185/189 subjects after treatment administration, with 68.3%, 73.0% and 65.1% of patients in the SB5, EU Humira and US Humira groups, respectively, exhibiting positive ADAs on Day 15 and 96.8%, 93.7% and 98.4% of patients in the SB5, EU Humira and US Humira groups, respectively, exhibiting positive ADAs on Day 71. The incidence of ADA development was not significantly different between the treatments. [1] Bevacizumab BI695502 (Boehringer Ingelheim) US and EU Avastin 1mg/kg Randomised, single-blind, single dose, three-arm, parallel group study (1:1:1) Healthy male volunteers (n=90) 90% CI for the ratio of treatment means for area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tz), from time zero extrapolated to infinite time (AUC0-∞) and maximal plasma concentration (Cmax) were within the pre-specified limits of 80-125% for the comparisons of BI695502 with US Avastin and BI695502 with EU Avastin, as well as for US and EU Avastin. Not reported. [2]
biosimilars-literature-review-september-2017.docx