Ensuring self-reliance and universal access to biologics – Part I

This conversation is about universal access to biologics, for India, and indeed for all developing countries. Most of the medicines that we take are ‘small molecule drugs’. They have fixed structures, and are produced by chemical reactions in a test tube, so to speak. Biologics, in contrast, are usually proteins which are enormously bigger molecules. Insulin is a good example. Proteins need to be folded correctly in order to function, and various conditions can cause them to misfold or aggregate. Also, because proteins are produced in living cells, and not in a test tube, the cells may modify the protein.

When a new drug is introduced into the market, the “originator company” has patent rights, meaning the exclusive right to manufacture that drug. This monopoly allows the manufacturer to sell the medicines at a very high price. Patents have a time-period, and after this term ‘expires’ the drug goes ‘off patent’, which means that now any company can manufacture it as a ‘generic drug’ (which is identical to the originator’s drug) without permission or the need to pay a royalty. India is a significant player in the global pharma industry, and most of our pharma companies manufacture generics. The competition between these companies helps to radically bring down the price of the generic drug. Biologics, too, experience a similar life cycle. However, for biologics the generic equivalent is called a biosimilar. Here, too, the price will drop dramatically once a biosimilar is on the market. But due to a number of barriers, the transition that India made to become a leader in generics has not fully taken place for biosimilars. But it could happen.