Lakshmi Prabha, R. Sai Pavithra1, T. N. Uma Maheswari

Abstract

Biologics are used in the treatment of immune-mediated diseases with the aim of modulating lymphocytes or cytokines. They can be categorized broadly into three categories: Tumor necrosis factor-alpha inhibitors, lymphocyte modulators, and interleukin inhibitors. Guidelines for the development of biologics include validations of various steps in development, standard guidelines, regulatory guidelines, manufacturing guidelines, and analytical tests. Hence, in this article, the guidelines and key aspects of guidelines in the use of biologics in oral diseases are presented.