Table 2.

Summary of DSN in cycle 1 (FAS-As Randomized and FAS-As Treated)

Analysis Set Statistic	Proposed biosimilar pegfilgrastim (APO-Peg)	US-licensed pegfilgrastim reference product (US-Neulasta®)	EU-approved pegfilgrastim reference product (EU-Neulasta®)	(APO-Peg)-minus (US-Neulasta®)	(APO-Peg)-minus (EU-Neulasta®)	(EU-Neulasta®) minus (US-Neulasta®)
FAS (As Randomized)
N	294	148	147	N/A	N/A	N/A
LS Mean in days	1.6	1.4	1.6	0.2	0.02	0.2
Median (Min, Max) in days	2.0 (0, 10)	1.0 (0, 5)	2.0 (0, 10)	N/A	N/A	N/A
95% CI in days	1.47 to 1.79	1.17 to 1.61	1.38 to 1.83	− 0.03 to 0.51	− 0.25 to 0.30	− 0.10 to 0.53
FAS (As Treated)
N	298	147	144	N/A	N/A	N/A
LS Mean in days	1.6	1.4	1.6	0.2	-0.01	0.2
Median (Min, Max) in days	1.5 (0, 10)	1.0 (0, 5)	2.0 (0, 10)	N/A	N/A	N/A
95% CI in days	1.46 to 1.77	1.17 to 1.61	1.41 to 1.86	− 0.04 to 0.50	− 0.29 to 0.26	− 0.07 to 0.56