Table 3.
Summary of ANC and CD34+ PD End Point Parameters Following a Fixed Single Subcutaneous Injection of 6 mg of Proposed Pegfilgrastim Biosimilar or Pegfilgrastim Reference Product to Healthy Subjects (PD Population)
| Proposed Pegfilgrastim | Pegfilgrastim Reference | |||
|---|---|---|---|---|
| Biosimilar, Arithmetic | Product, Arithmetic | Relative Meana | ||
| End Points | Mean (SD), n = 56 | Mean (SD), n = 56 | Ratio, % | 95%CI |
| ANC PD Parameter | ||||
| AUECt (cells × 109·h/L) | 4749.85 | 4817.55 | 98.8 | 96.0–101.6 |
| (1247.09) | (1314.54) | |||
| Emax (cells × 109/L) | 29.75 | 30.94 | 96.3 | 92.6–100.1 |
| (7.99) | (8.72) | |||
| Tmax (h) | 63.43 | 60.86 | 103.8 | 96.1–111.4 |
| (16.54) | (18.94) | |||
| CD34+ Count PD Parameter | ||||
| AUECt (cells·h/μL) | 7153.34 | 6991.64 | 105.9 | 99.5–112.7 |
| (5187.76) | (6798.59) | |||
| Emax (cells/μL) | 78.82 | 76.03 | 106.8 | 98.7–115.5 |
| (50.02) | (67.34) | |||
| Tmax (h) | 94.07 | 96.64 | 97.6 | 94.0–101.3 |
| (12.06) | (14.55) | |||
Based on the least‐squares estimates of the geometric means of AUECt and Emax and based on the least‐squares estimates of the arithmetic means for Tmax.