A Comparative Study of Regulatory Compliance for Biosmilars in US, EU and INDIA

Abstract

A biosimilar is a medicinal product with a similar safety, efficacy, and quality as an already authorized biologic product. It is made by or derived from a biological source such as yeast or a bacterium. Thus, the lack of significant differences has to be clinically proven by appropriate development of each biosimilar. Biosimilars contain different inactive ingredients and may have different brand names, appearance, and packaging from the reference medicinal product. Several expressions have been used in the U.S., the European Union (EU), Canada, There is currently no global consensus regarding the source of reference products, although WHO guidelines have outlined fundamental principles and key considerations in the selection of reference products for the development of biosimilars. Further, WHO guidelines stipulate that only a reference product that was licensed on the basis of a complete registration dossier can serve as a reference product (i.e., an approved biosimilar cannot serve as the reference product in the development of another biosimilar). The study aims to evaluate the regulatory compliance for biosmilars in US, EU and India. Currently there are seven biosimilars approved in the United States. The most recent, biosimilar bevacizumab, was approved in September, 2017. In the case of infliximab and its biosimilar, it is likely that greater price differences will have to be seen before physicians will be convinced to switch away from the reference product. The reluctance of both patients and physicians to switch to a biosimilar may imply that increases in market shares for biosimilars will be a matter of time as more biologic-naïve patients are placed on biosimilars to begin their treatment regimen Biosimilar are not generic; biologics are larger and more complicated than chemical drugs, due to the complexity of biological/biotechnology derived products the generic approach is scientifically not appropriate for biosimilar products. There is need to use well-designed clinical trials to establish biosimilarity.