Abstract

REVIEW OF BIOSIMILARS FOR CANCER, ULCERATIVE COLITIS AND IT’S CURRENT STATUS WITH ONGOING CHALLENGES

Dr. Sunita Ogale*, Mahadev Tate, Shreya Parkar

ABSTRACT

A biosimilar is a biological product that is highly similar to licensed biologic (originator) such that there are no clinically meaningful differences in potency and safety between the biosimilars and originator i.e. manufactured by different company. It can be manufactured when the original products patent expires. The Food and Drug Administration has approved ten different biosimilars, and the European Medicines Agency has approved 40.[23] The goal of this article is to describe the chemical and clinical nature of biosimilars, review focus areas of interest for biosimilar development in oncology and ulcerative colitis. Biosimilars can not be viewed as generics because generics must be identical to the reference product.

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