Volume :

2

Issue :

4

Abstract :

Biosimilars are having massive demand in future in order to provide good quality therapy for human well-being. Biosimilars also pronounced as biologics / biopharmaceuticals / follow-on biologics / subsequent entry biologics (SEB’s) with the statement of a biopharmaceutical drug deigned to have active properties similar to one that has previously been licensed. As per WHO biosimilars are defined as “a bio therapeutic product which is similar in terms of quality, safety and efficacy to an already licensed referenced bio therapeutic product”. Biosimilars can relieve the financial burden on healthcare systems and expand patient accessibility. This review embraces the significance, regulatory consideration, available regulatory guidelines and current market scenario on biosimilars.