chapter  Chapter 3
54 Pages

European regulatory guidance

WithSarfaraz K. Niazi

The European Medicines Agency guideline lays down the nonclinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed. The nonclinical section addresses the pharmacotoxicological assessment. Generally, the differences observed in the physicochemical and biological analyses will guide the planning of the nonclinical studies. The safety profile of the reference product will determine the focus of the safety studies both pre- and postmarketing. The Committee for Medicinal Products for Human Use has issued product-class-specific guidelines to facilitate the nonclinical development of biosimilar medicinal products in certain areas. Results from the physicochemical and biological characterization studies should be reviewed from the point of view of potential impact on efficacy and safety. The studies should assess the concentration-activity/binding relationship between the biosimilar and the reference medicinal product covering a concentration range where differences are most sensitively detected.