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. 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”.
Notably, biologics are more expensive to develop and manufacture than small-molecule drugs and typically require a longer time to reach the market. A reference biologic drug enjoys up to 12 years of FDA market exclusivity, meaning the FDA cannot approve a biosimilar for at least 12 years from the reference product’s initial approval.
While generic versions of small-molecule drugs can be chemically synthesised with exact replication, creating identical versions of reference biologics is impossible due to their complexity. Biosimilars, like their reference biologics, are produced in living cells, requiring expertise and cutting-edge technology for development and manufacturing.
Since biologics are derived from living cells and have highly complex structures, each batch of a branded biologic drug exhibits slight variations―a phenomenon known as microheterogeneity. The acceptable limits of microheterogeneity in a branded biologic define the range of similarity a biosimilar must fall within. In other words, a biosimilar must be as similar to the reference biologic as the reference biologic is to itself.
Unlike small-molecule drugs, which only require human studies to demonstrate bioequivalence, biosimilar manufacturers must conduct clinical trials to establish the safety and efficacy of their proposed product.
Europe was the first to establish a policy framework for approving biological products, with the European Medicines Agency approving the first biosimilar, Omnitrope, in 2006. However, India approved its first biosimilar much earlier―in 2000, for hepatitis B―despite lacking a formal regulatory framework at the time. In June 2012, India finally introduced its own biosimilar guidelines. And this year marks the 25th anniversary of India’s first biosimilar approval.
Over the past decade, India has emerged as a major player in the biosimilars market, boasting the highest number of approved biosimilars. Currently, more than 100 Indian biopharmaceutical companies are engaged in manufacturing and marketing biosimilars. According to an August 2022 McKinsey report, over 55 blockbuster biologics are set to lose patent protection globally between 2022 and 2032. Experts believe Indian manufacturers can very well capitalise on this, not only by offering affordable alternatives to expensive biologics but also by tapping into the global biosimilars market. Biosimilars contribute $2.2 billion to India’s $32 billion pharmaceutical industry. Projections suggest this figure could soar to $40 billion by 2030.