SAR342434 Humalog Randomised, Participants with 6/25 participants No [2] (Sanofi) (Lilly) 2 × type I diabetes reported 14 infusion hypersensitivity two-arm with at least 6 set occlusion events reactions or crossover study months of whilst receiving allergic reactions continuous SAR342434 as subcutaneous compared to 4/27 insulin infusion participants reporting treatment 9 events whilst receiving Humalog. The event rate of any hypoglycemia was similar with SAR342434 (7.15) Humalog (7.98) Rituximab RTXM83 MabThera Population Participants with 90%CI for the ratio Median values for [3] (mAbxience pharmacokinetic diffuse large B-cell between the drug clearance Research S.L) modelling of lymphoma geometric means of were similar phase III clinical the between (RTXM83=127, data from time zero antibody MabThera=214; extrapolated to positive and serum infinite time (AUCinf) negative subjects concentrations: and maximal plasma in both RTXM83 RTXM83=2703 concentration (Cmax) (10.8 vs 11.3 mL/ MabThera=2638) were within the min, respectively) predefined and MabThera bioequivalence groups (13.6 vs interval of 0.80–1.25 11.3 mL/min, respectively) Trastuzumab CT-P6 Herceptin Single-dose, Healthy adult 90% CI for the ratio No participants [4] (Celltrion) (US) randomised, male volunteers of geometric least were positive for double-blind, (n=70, square means for anti-drug parallel group randomised 1:1) area-under-the-curve antibodies. study from time zero extrapolated to infinite time (AUCinf), AUC from time 0 to last quantifiable concentration (AUClast) and maximal plasma concentration (Cmax) were within the prespecified limits of 80- 125% for the comparisons of CT-P6 with US Herceptin
SAR342434 (Sanofi) Humalog (Lilly) Randomised, 2 × two-arm crossover study Participants with type I diabetes with at least 6 months of continuous subcutaneous insulin infusion treatment 6/25 participants reported 14 infusion set occlusion events whilst receiving SAR342434 as compared to 4/27 participants reporting 9 events whilst receiving Humalog. The event rate of any hypoglycemia was similar with SAR342434 (7.15) Humalog (7.98) No hypersensitivity reactions or allergic reactions [2] Rituximab RTXM83 (mAbxience Research S.L) MabThera Population pharmacokinetic modelling of phase III clinical data Participants with large B-cell lymphoma (RTXM83=127, MabThera=214; serum concentrations: RTXM83=2703 MabThera=2638) 90%CI for the ratio between the geometric means of the from time zero extrapolated to infinite time (AUCinf) and maximal plasma concentration (Cmax) were within the predefined bioequivalence interval of 0.80–1.25 Median values for drug clearance were similar between antibody positive and negative subjects in both RTXM83 (10.8 vs 11.3 mL/ min, respectively) and MabThera groups (13.6 vs 11.3 mL/min, respectively) [3] Trastuzumab CT-P6 (Celltrion) Herceptin (US) Single-dose, randomised, double-blind, parallel group study Healthy adult male volunteers (n=70, randomised 1:1) 90% CI for the ratio of geometric least square means for area-under-the-curve from time zero extrapolated to infinite time (AUCinf), AUC from time 0 to last quantifiable concentration (AUClast) and maximal plasma concentration (Cmax) were within the prespecified limits of 80- 125% for the comparisons of CT-P6 with US Herceptin No participants were positive for anti-drug antibodies. [4] diffuse
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