Abstract

Biosimilars are biotechnologically manufactured products that enter the market as and when the original biopharmaceutical goes off patent. As the name suggests, they are only “similar” and not exact versions of the originator product. The manufacturing process of biosimilars is complex, the product prone to variation, and regulatory approval rules are more extensive and elaborative than required for generic versions of chemically synthesized drugs. This makes the field of biosimilars interesting and inquisitive for research. As biosimilars are essentially protein drugs manufactured in living cells, immunogenicity becomes a major issue in almost all biopharmaceuticals. This increases the importance of Risk Management Plan (RMP) and pharmacovigilance. Since biosimilars are not identical copies of innovator products, the regulatory facets of indication extrapolation, automatic substitution, and interchangeability are more stringent than those available for small molecule generic drugs. This article discusses all these sectors significant to the world of biosimilars. Prospectively, biosimilars have the potential to deliver effective cost savings for healthcare users and thus they are a critical part of the biopharmaceutical industry.

Keywords: Biopharmaceuticals, biosimilars, immunogenicity, manufacturing, pharmacovigilance, regulations, risk management.

Graphical Abstract