safety

The term biosimilar is used for a subsequently launched version of a biologic product which is similar in terms of quality, safety, and efficacy to an already licensed “Reference Biologic” product. The primary purpose of biosimilars is to reduce the healthcare costs associated with the use of biologics and thereby increase access to healthcare. Unlike small molecule generics, the bioequivalence approach is not considered appropriate for the approval of biosimilars. The approval of biosimilars is based on a stepwise comparability exercise with the “Reference Biologic”, starting with a comprehensive physicochemical and biological characterization. The extent and nature of the required nonclinical in vivo studies and clinical studies depend on the level of evidence obtained from the previous steps. Regulations require that the “Reference Biologic” should have been licensed/approved in the same country/region or in other ICH countries based on a full registration dossier. Apart from the comparability exercise, regulations also deal with indication extrapolation, pharmacovigilance, and substitution and interchangeability. This chapter also briefly describes the considerations for exclusivity, market access, and commercialization of biosimilars.