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 |