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Table 3 Summary of pharmacokinetic similarity analysis in Study 1 and Study 2

From: Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

  Ratio of geometric LS mean (90% CI)
Study 1 Study 2
FKB327 / RP FKB327 / RP
Parameters ANOVA ANCOVAa ANOVA ANCOVAa
Cmax 1.07 (0.99, 1.16) 1.06 (0.99, 1.13) 1.05 (1.00, 1.11) 1.05 (1.01, 1.10)
AUC0-t 1.17 (1.05, 1.30)b 1.15 (1.04, 1.28) b 1.11 (1.01, 1.23) 1.12 (1.01, 1.23)
AUC0-∞ 1.16 (1.03, 1.31) b 1.16 (1.04, 1.29) b 1.11 (0.99, 1.24) 1.12 (1.00, 1.25)b
AUC0–360 1.10 (1.01, 1.19) 1.08 (1.01, 1.16) 1.04 (0.98, 1.10) 1.04 (0.99, 1.10)
T1/2 1.14 (0.97, 1.35)b 1.14 (0.97, 1.34)b 1.02 (0.86, 1.22) 1.02 (0.85, 1.22)
  1. aANCOVA: Body weight and age in both Study 1 and Study 2, and site added in Study 2 as covariates
  2. bData did not meet prespecified equivalence criteria of 0.80 to 1.25
  3. ANCOVA Analysis of covariance; ANOVA Analysis of variance; AUC0-∞ Area under the concentration-time curve from time zero to infinity; AUC0–360 Area under the concentration-time curve from time zero to 360 h; AUC0-t Area under the concentration-time curve from time zero to the last measurable concentration; Cmax Maximum serum concentration; RP Reference product; T1/2 Half-life