Regulatory Aspects of Biologics In India, USA And Europe

Abstract

Biologics has been a category in pharmaceuticals for almost a decade now. Increased market need for biologics accounts due to various reasons like big brand name companies losing patent extensions, increased need for biologics as therapeutic interventions in chronic diseases, increased initiatives taken up by governments, and rising regulatory convergence and better healthcare facilities for all nations. Hence which also demands for well-defined and structured protocols and procedures for manufacturing, approval, and marketing authorization for these, this study will provide an approach for understanding these regulatory aspects of biologics in the USA, Europe, and India.