A Review of Biosimilar as Medicine

Abstract

Biosimilars are a growing drug class designed to be used interchangeably with biologics. Biologics are created in living cells and are typically large, complex proteins that may have a variety of uses. Within the field of gastroenterology alone, biologics are used to treat inflammatory bowel diseases, cancers, and endocrine disorders. A biosimilar is a drug that is highly similar, but not necessarily identical, to a biologic drug (i.e., the reference drug) and shows no clinically significant differences in safety, purity, or potency. Biosimilar development does not establish safety and efficacy, but rather shows bio similarity to the reference drug. Unlike generic drugs, biosimilars are not an exact copy of their reference drug because of differences in the manufacturing.