LBEC0101 Enbrel 25mg Randomised, Healthy 90% CI for the All subjects were [6] (LG Chem Ltd) double-blind, volunteers ratio of treatment anti-drug antibody single dose, (Korean means for area (ADA) negative two-treatment, n=43 under the before the first crossover completed dose. Five subjects study PK analysis) curve from showed a positive time zero to the ADA result after last quantifiable conduct of Period 1, concentration of which 1 received (AUClast), LBEC0101 and 4 received Enbrel. An from time zero additional 2 extrapolated to subjects showed a infinite time positive ADA results (AUCinf) and after conduct of maximal plasma Period 2, both of concentration which received (Cmax) were Enbrel. The within the pre- incidence of ADA limits of development was 80-125% for the not significantly comparison different between between the treatments. LBEC0101 and Enbrel Trastuzumab ABP 980 US and EU Randomised, Healthy 90% CI for the trial were no pre- [7] (Amgen Inc) Herceptin single-blind, volunteers of treatment existing binding single dose, (n=148) means for area ADAs detected at (trastuzumab) three-arm, under the baseline and no parallel group subjects developed study (1:1:1) curve from binding or time zero to the neutralising ADAs at last quantifiable the end of the concentration study. (AUClast), from time zero extrapolated to infinite time (AUCinf) and maximal plasma concentration (Cmax) were within the limits of 80-125% for the comparisons of ABP 980 with US Herceptin and ABP 980 with EU Herceptin, as well as for US and EU Herceptin. Bevacizumab
LBEC0101 (LG Chem Ltd) Enbrel 25mg Randomised, double-blind, single dose, two-treatment, crossover study Healthy volunteers (Korean n=43 completed PK analysis) 90% CI for the ratio of treatment means for area under the 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 limits of 80-125% for the comparison between LBEC0101 and Enbrel All subjects were anti-drug antibody (ADA) negative before the first dose. Five subjects showed a positive ADA result after conduct of Period 1, of which 1 received LBEC0101 and 4 received Enbrel. An additional 2 subjects showed a positive ADA results after conduct of Period 2, both of which received Enbrel. The incidence of ADA development was not significantly different between the treatments. [6] Trastuzumab ABP 980 (Amgen Inc) US and EU Herceptin (trastuzumab) Randomised, single-blind, single dose, three-arm, parallel group study (1:1:1) Healthy volunteers (n=148) 90% CI for the of treatment means for area under the 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 limits of 80-125% for the comparisons of ABP 980 with US Herceptin and ABP 980 with EU Herceptin, as well as for US and EU Herceptin. were no binding ADAs detected at baseline and no subjects developed binding or neutralising ADAs at the end of the study. [7] Bevacizumab existing pre- pre- trial
biosimilars-literature-review-june-2017.docx