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)ImportanceSensitivity
Physicochemical data demonstrating structural similarity7.237.057.307.247.077.56
In vitro and in vivo data demonstrating similarity in biological activity7.767.747.667.587.467.82
PK and PD data demonstrating similarity7.947.858.107.837.758.10
Clinical study data demonstrating similar efficacy8.658.568.728.618.578.75
Clinical study data demonstrating similar safety8.808.788.838.758.728.79
Clinical study data demonstrating similar immunogenicity8.
Clinical study data demonstrating the ability to switch from reference to biosimilar and vice versa without impairing safety or efficacy8.
  • Weighted average of prescribers’ responses, by region, on a scale of 1 (not important/sensitive) to 10 (very important/sensitive).

  • PD, pharmacodynamic;PK, pharmacokinetic.