Biosimilar Reference PK Outcomes (and Immunogenicity Study Design Reference Candidate Product Population PD trial reported) Outcomes Etanercept PF-06438179 / Remicade Randomised Healthy 90%CI for the Anti-drug antibodies [2] GP1111 (EU and US) subjects between the were detected in three arm PK (n=151, geometric means PF-06438179 / study randomised of the GP1111: 1:1:1) from 6 of 37 (16.2%) time zero extrapolated to Remicade (EU): infinite time 14 of 43 (32.6%) (AUCinf), AUC from Remicade (US): time 0 to the last 11 of 39 (28.2%) measurable concentration (AUCT) and maximal plasma concentration (Cmax) were within the predefined bioequivalence interval of Peg-filgrastim
Biosimilar Candidate Reference Product Study Design Population PK Outcomes (and PD reported) Immunogenicity Outcomes Reference Etanercept PF-06438179 / GP1111 Remicade (EU and US) Randomised three arm PK study Healthy subjects (n=151, randomised 1:1:1) 90%CI for the between the geometric means of the from time zero extrapolated to infinite time (AUCinf), AUC from time 0 to the last measurable concentration (AUCT) and maximal plasma concentration (Cmax) were within the predefined bioequivalence interval of Anti-drug antibodies were detected in PF-06438179 / GP1111: 6 of 37 (16.2%) Remicade (EU): 14 of 43 (32.6%) Remicade (US): 11 of 39 (28.2%) [2] Peg-filgrastim trial
biosimilars-literature-review-june-2018.docx