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

Table 2 Summary of pharmacokinetic parameters in Study 1 and Study 2

	Geometric Mean Parameter Estimate (Geometric CV)^a
	Study 1				Study 2
	FKB327 N = 65		RP N = 65		FKB327 N = 65		RP N = 65
	n	value	n	value	n	value	n	value
C_max (ng/mL)	65	3920 (25.2)	65	3650 (29.5)	65	3920 (19.1)	65	3710 (17.5)
AUC_0-t (h•ng/mL)	65	2,540,000 (36.7)	65	2,180,000 (41.3)	65	2,620,000 (38.5)	65	2,350,000 (33.7)
AUC_0-∞ (h•ng/mL)	55	2,770,000 (37.5)	58	2,380,000 (41.9)	56	2,830,000 (40.6)	58	2,550,000 (35.9)
AUC_0–360 (h•ng/mL)	65	1,170,000 (26.3)	65	1,070,000 (32.2)	65	1,130,000 (21.3)	65	1,080,000 (20.2)
T_1/2 (h)	55	330.487 (53.7)	58	288.644 (58.2)	56	281.084 (60.8)	58	275.219 (61.8)

^aMeasured values (no correction for protein content of drugs) were used for the analysis in Study 1 and Study 2
AUC_0-∞ Area under the concentration-time curve from time zero to infinity; AUC_0–360 Area under the concentration-time curve from time zero to 360 h; AUC_0-t Area under the concentration-time curve from time zero to the last measurable concentration; C_max Maximum serum concentration; CV Coefficient of variation; RP Reference product; T_1/2 Half-life

ISSN: 2050-6511