Table 1.
Prescribers’ responses rating the importance and sensitivity of different data types in determining the suitability of a biosimilar for use
| Type of data (weighted average) | Importance | Sensitivity | ||||
| All | Europe | Asia-Pacific | All | Europe | Asia-Pacific | |
| Physicochemical data demonstrating structural similarity | 7.23 | 7.05 | 7.30 | 7.24 | 7.07 | 7.56 |
| In vitro and in vivo data demonstrating similarity in biological activity | 7.76 | 7.74 | 7.66 | 7.58 | 7.46 | 7.82 |
| PK and PD data demonstrating similarity | 7.94 | 7.85 | 8.10 | 7.83 | 7.75 | 8.10 |
| Clinical study data demonstrating similar efficacy | 8.65 | 8.56 | 8.72 | 8.61 | 8.57 | 8.75 |
| Clinical study data demonstrating similar safety | 8.80 | 8.78 | 8.83 | 8.75 | 8.72 | 8.79 |
| Clinical study data demonstrating similar immunogenicity | 8.24 | 8.24 | 8.10 | 8.30 | 8.23 | 8.41 |
| Clinical study data demonstrating the ability to switch from reference to biosimilar and vice versa without impairing safety or efficacy | 8.07 | 8.02 | 8.27 | 8.11 | 8.02 | 8.36 |
Weighted average of prescribers’ responses, by region, on a scale of 1 (not important/sensitive) to 10 (very important/sensitive).
PD, pharmacodynamic;PK, pharmacokinetic.