Table 2.
Characteristics of pharmacokinetic parameters in both groups
| PK parameter | Parameter | Group A (Biosimilar) | Group B (Originator) | P (mu) |
|---|---|---|---|---|
| Cmin, µg/mL | M | 64.89 | 94.13 | 0.065 |
| SD | 25.96 | 58.76 | ||
| Cmax, µg/mL | M | 351.35 | 407.45 | 0.635 |
| SD | 114.44 | 263.63 | ||
| Ctrough, µg/mL | M | 92.19 | 131.16 | 0.075 |
| SD | 33.26 | 73.49 | ||
| AUCt,ss, µg*h/mL | M | 53,579.37 | 70,612.81 | 0.123 |
| SD | 20,853.74 | 33,648.98 | ||
| Tmax, h | M | 4.26 | 1.26 | 0.415 |
| SD | 7.83 | 0.55 | ||
| Kel, h−1 | M | 0.0034 | 0.0028 | 0.236 |
| SD | 0.0016 | 0.0011 | ||
| T1/2, h | M | 375.08 | 277.00 | 0.236 |
| SD | 598.62 | 83.75 | ||
| MRT, h | M | 536.63 | 408.15 | 0.206 |
| SD | 858.25 | 135.57 | ||
| CL, mL/h | M | 11.97 | 8.50 | 0.053 |
| SD | 6.14 | 3.56 | ||
| Vss, L | M | 3.80 | 3.29 | 0.385 |
| SD | 1.23 | 1.19 |
Notes: Cmin, minimum product concentration; Cmax, maximum product concentration; Ctrough, minimum product concentration at the end of the dosing interval after establishing a stationary distribution; AUCt,ss, area under the concentration–time curve during the dosing interval after establishing a stationary distribution; Tmax, h, time to reach the maximum product concentration; Kel, elimination constant; T1/2, half-life; MRT, mean retention time; CL, clearance; Vss, stationary specific volume of distribution