Immunogenicity study of biosimilar candidates

EDUARDO MUFARREGE; LUCÍA PEÑA; FLORENCIA RIVAROSA; MARINA ECHEVERRIGARAY

Drug Development and Safety

IntechOpen

Lugar: Londres; Año: 2023;

Therapeutic proteins can induce undesirable immune reactions in the patient and constitute a major concern as they may compromise therapy safety and efficacy. During the comparability study between a biosimilar product and the innovator, several attributes are considered. Among them, the comparative immunogenicity analysis in pre-clinical and clinical stages has a major relevance. In this chapter, we will describe the most used experimental platforms for biotherapeutic immunogenicity characterization. Special emphasis will be placed on in vitro assays for the detection of contaminants that modulate innate immune responses, as well as tools for the identification of biologic-derived T cell epitopes. Likewise, we will also review the current trials used for the detection of Host Cell Proteins (HCPs) and their potential impact on protein immunogenicity. Finally, we will analyze the admissibility criteria established by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) when comparing the immunogenicity of reference products and biosimilar candidates.