Table 2.

Critical quality attributes (CQA) and similarity demonstration products [12,40].

Comparability Critical Attributes	Similarity Demonstration
Protein structure and production quality	Extensive laboratory analysis for all molecular characteristics (multiple lots)
Pharmacokinetics, Pharmacodynamics, and Animal Toxicity	In vitro and in vivo assays (carried out on relevant animal species, if further confirmation scans are required for laboratory studies)
Pharmacokinetics, Pharmacodynamics, and Animal Toxicity	Phase I clinical studies
Clinical Efficacy and Safety	Phase III clinical studies
Safety in clinical practice	Risk management plan Phase IV studies Pharmacovigilance