r-hGH Genotropin Randomised, Healthy Pharmacokinetics Not assessed. [12] (Cristália Pfizer 12.8IU open-label, adult 90% CIs of the Produtos single-dose, volunteers geometric mean ratios Químicos crossover (n =38; of AUClast, AUCinf and Farmacêuticos) study 19M/19F; Cmax were within the 34PPP) prespecified acceptance criteria of 80-125%. Pharmacodynamics 90% CIs of the geometric mean ratios of each of the PD parameters (AUECt and Emax for IGF-1 and IGFBP-3) were fully contained within range of Biosimilar Reference Study PK Outcomes (and PD Immunogenicity Study Design Reference Candidate Product Population reported) Outcomes Rituxumab
r-hGH (Cristália Produtos Químicos Farmacêuticos) Genotropin Pfizer 12.8IU Randomised, open-label, single-dose, crossover study Healthy adult volunteers (n =38; 19M/19F; 34PPP) Pharmacokinetics 90% CIs of the geometric mean ratios of AUClast, AUCinf and Cmax were within the prespecified acceptance criteria of 80-125%. Pharmacodynamics 90% CIs of the geometric mean ratios of each of the PD parameters (AUECt and Emax for IGF-1 and IGFBP-3) were fully contained within range of Not assessed. [12] Biosimilar Candidate Reference Product Study Design Study Population PK Outcomes (and PD reported) Immunogenicity Outcomes Reference Rituxumab
biosimilars-literature-review-december-2016-update.docx