Taking shape: biosimilar rules in India

The Indian government has invited public comments on draft regulatory guidelines for biosimilars, while patent law in this area has still to take shape. Sameer Sah, Nisha Austine and Jahnvi Shah of Khaitan & Co report.

Biologics are large, structurally complex proteins derived from living cells such as bacteria, yeasts or mammalian cells. In comparison to a small molecule or chemical drug, biologics may be 200 to 1,000 times bigger, with high molecular complexity. Biologics include therapeutic proteins and monoclonal antibodies. Biologics that are similar to each other in terms of safety, efficacy and quality to a reference biologic product are referred to as biosimilars.

Due to the complexity of their structures, the discovery process and subsequent manufacturing of biologics is a challenging affair. Even a slight alteration in the composition of a biologic can alter the resulting drug’s efficacy significantly. Comparatively, the discovery process of a biosimilar is bound to be more cost and time effective as the intention is to reproduce and create an almost the same/similar product as the reference biologic, as opposed to creating a completely new product altogether.

While both products retain their complexities in manufacturing, and require robust processes for validation and change control, the reduced expenditure on the discovery process allows biosimilars to be priced more competitively than the reference biologic.