Banking on biosimilars

The pharmaceutical industry is experiencing a biosimilar boom, and India is among the best-positioned countries to capitalise on it. Biosimilars are biological medicines that closely resemble an already-approved reference biologic.

- NIRMAL JOVIAL

They are designed to match the reference drug in safety, efficacy and quality, though they are not identical due to the inherent complexity of biologics, which are derived from living organisms. Today, biosimilars are widely used to treat conditions such as cancer, autoimmune disorders and chronic diseases like diabetes.

To illustrate the scale of this boom: The US FDA approved its first biosimilar in 2015; fast forward to 2024, and biosimilars account for 36 per cent of the 50 drugs approved.

Biologic drugs, which primarily consist of proteins produced by human, animal or microbial cells, are significantly more complex than chemical drugs. A biologic can contain up to 50,000 atoms, earning them the classification of "large molecule drugs", whereas chemical drugs, composed of 20 to 200 atoms, are known as "small molecule drugs".