Why Analytical Similarity Cannot Be Reduced to a Single Number: A Hierarchical Evidence Model for Biosimilar Comparability

Analytical similarity is foundational to biosimilar development, yet modern comparability programs generate heterogeneous evidence that cannot be represented adequately by one composite score. This article proposes an original hierarchical evidence model that preserves attribute identity across structural, physicochemical, functional, clinical-consequence, residual-uncertainty, and decision-response layers. The model rejects context-free compensation because extensive agreement among low-critica