Biosimilars and the need for a policy prescription

To understand the class of drugs known as biosimilars, it is first necessary to understand the class of drugs described as biologics.

- Ranga Reddy

Traditionally, biologics were derived through natural processes from living organisms. For example, one of the earliest biological drugs dating back to the 19th century was the anti-diphtheria serum, which was manufactured from the serum extracted from horses that contained antibodies to the disease. The biotechnology revolution spurred by the invention of gene-splicing technology by Cohen-Boyer opened the door for the creation of more effective biologicals like trastuzumab, which revolutionised the treatment of a specific type of breast cancer by targeting cancerous cells. The more recent biologicals, starting with trastuzumab, typically contain monoclonal antibodies which are manufactured in the cells of genetically-modified organisms. These monoclonal antibodies are adapted with the help of biotechnology to target specific types of cells associated with cancer or other diseases for which these drugs are developed. Given the complexity of developing and manufacturing biologicals, especially monoclonal antibodies, it is no surprise that biologicals are astronomically priced. Countries around the world have been keen to ensure more competition in the market by allowing competitors to manufacture and market copies of biologicals. These copies are called biosimilars. There is plenty of empirical evidence demonstrating that increased competition in the case of small molecule drugs leads to significant price erosion, thereby improving accessibility and reducing costs to patients. These small-molecule drugs, unlike biologicals, are not manufactured in living organisms and therefore, it is easier to control their manufacturing process. Countries like India have an abundance of talent with the skills to reverse-engineer these drugs to manufacture generic copies of novel small molecule drugs (for e.g. paracetamol) leading to more competition and reduced prices. Replicating the success story of generic small molecule drugs in India wi