How to assess the efficacy, safety, and immunogenicity of biosimilar medicinal products?
In assessing the efficacy of biosimilars, the tests applied to generic drugs are necessary but not sufficient. Physicochemical tests may not discriminate variants or impurities, and can alter the product tested. Biological tests are sometimes imprecise, as they do not measure all activities and may therefore fail to detect a clinically important activity. Comparative pharmacokinetic and pharmacodynamic studies in animals may be of limited value because of species-specific characteristics (affinity for receptors, clearance). It is therefore necessary to conduct clinical trials to assess the efficacy of a biosimilar medicinal product.