Abstract

A REVIEW ON BIOSIMILARS AND THEIR GLOBAL STANDARDS

Reeta M., Arokiya Pani Selciya A., Vigneshwaran L. V. and Senthil Kumar M.*

ABSTRACT

Biosimilars are goods that are very similar in terms of quality, biological activity, safety, and efficacy to the reference product. Because biosimilars are biological products rather than generic pharmaceuticals, they are not subject to the same regulatory oversight as generic compounds. To demonstrate biosimilarity in regulatory markets around the world, rigorous early-stage structural, functional, and analytical testing is necessary, followed by nonclinical and clinical assessments comparing a biosimilar to its reference product. However, maintaining consistency in quality, safety, and efficacy while minimising the risk of divergence during life-cycle management is critical to the long-term success of these drugs. In October 2019, the World Health Organization (WHO) Expert Committee on Biological Standardization established the WHO 1st International Standard (IS) for Adalimumab (coded 17/236) with a defined unitage ascribed to each of the individual bioactivities evaluated in the study: TNF-a binding, TNF-a neutralisation, complement dependent cytotoxicity, and antibody-dependent cellular cytotoxicity.

Keywords: Biosimilar, Evaluating biosimilarity, Biosimilarity medications, Medical system.