Table 2.
Summary of the standard curve data for the 3 test products in the human PK prototype assay
| Concentration ng/mL | Biosimilar Instrument Response | FDA-licensed Instrument Response | EU-authorized Instrument Response | Mean Instrument Response | SD | %CV |
|---|---|---|---|---|---|---|
| 50 | 618 | 607 | 549 | 591 | 37.1 | 6.3 |
| 100 | 1219 | 1183 | 1063 | 1155 | 81.5 | 7.1 |
| 500 | 5791 | 5808 | 5059 | 5552 | 427 | 7.7 |
| 1000 | 11640 | 11064 | 10338 | 11014 | 652 | 5.9 |
| 2500 | 27978 | 27697 | 26378 | 27351 | 854 | 3.1 |
| 6250 | 66845 | 64361 | 64291 | 65165 | 1455 | 2.2 |
| 12500 | 123154 | 123985 | 128814 | 125317 | 3057 | 2.4 |
| 20000 | 177747 | 172654 | 194467 | 181623 | 11411 | 6.3 |
| 25000 | 213273 | 210399 | 226203 | 216625 | 8418 | 3.9 |
%
CV: coefficient of variation, calculated as ((SD/mean concentration) x 100).
%
Bias: [(observed-nominal (ng/mL))/nominal (ng/mL)] x 100.