A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01)

• Published in: Expert review of clinical immunology Vol. 14; no. 4; p. 329
• Main Authors: Palaparthy, Ramesh, Udata, Chandrasekhar, Hua, Steven Y, Yin, Donghua, Cai, Chun-Hua, Salts, Stephanie, Rehman, Muhammad I, McClellan, Joseph, Meng, Xu
• Format: Journal Article
• Language: English
• Published: England 03.04.2018
• Subjects: Adolescent; Adult; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Female; Humans; Infliximab - administration & dosage; Infliximab - adverse effects; Infliximab - pharmacokinetics; Male; Middle Aged; Pharmacokinetics; infliximab; safety; immunogenicity; biosimilar
• ISSN: 1744-8409
• DOI: 10.1080/1744666X.2018.1446829

To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively. PK similarity was established if the 90% confidence intervals (CIs) of the test-to-reference ratios for PK parameters, C , AUC , and AUC , were within the 80.00-125.00% pre-specified equivalence window. Of 151 subjects randomized, 146 received study treatment; 130 were eligible for PK similarity assessment. Serum concentration-time profiles were similar across the three treatments. The 90% CIs for test-to-reference ratios for C , AUC , and AUC were within 80.00-125.00% for comparison of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. Similar numbers of subjects across treatment groups experienced adverse events. Anti-drug and neutralizing antibody profiles were largely similar among groups. This study demonstrated PK similarity of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. All three products displayed comparable safety and immunogenicity profiles. CT.gov identifier NCT01844804.