A Systematic Review of Regulatory requirements of Biosimilar Products: WHO, India, European Union and USFDA

Abstract

A biosimilar is a copy of an approved original biologic drug. Call for biosimilars is triggered by the expiration of the data protection on the original biologic medicine. A similar biologic biopharmaceutical product has been approved by the European Medicines Agency (EMA) because of its similarity in quality, safety, and efficacy to an innovator biologic product. Many nations, including Canada, Japan, the United States, India, and Korea, have released their own standards for evaluating follow-on biologics, based on WHO and EMA guidelines. When it comes to licensing biosimilar products/entities, this page discusses widely accepted criteria, with the goal of guaranteeing quality, safety and efficacy after full licensing dossier submission and license approval. Clinical and non-clinical data obtained with a previously licensed similar biologic medicinal product will be used in part to evaluate the degree of similarity between biosimilar and innovator biologic products for the licensing process. National regulatory frameworks can be built on these guidelines to license the products in question. It is the purpose of this article to discuss the numerous regulatory requirements for biosimilar clearance, including the WHO and several areas, such as India and the EU, as well as the US.