Introduction
Founded by Dr. K.I. Varaprasad Reddy in 1993, Shantha Biotechnics was one of the first Indian biotech to create a recombinant product, obtaining World Health Organization (WHO) prequalification for its Hepatitis B vaccine in 2002. Then, the firm grown to 750 employees and brought 11 novel products to market. In 2009, Shantha sold over 120 million doses of Hepatitis B vaccine to dozens of developing countries around the world and had revenues exceeding USD$90 million [1]. Later, in 2019, Shantha Biotechnics was acquired by the multinational giant Sanofi-Aventis (France) at a valuation of USD$784 million.
The example given above shows how profitable is to produce biosimilars in India when its environment provides easy regulations and production. In India, the first “similar biologic” was approved and marketed much before the U.S. approved its first biosimilar in 2015.
About 100 protein biosimilars are currently available in the market and according to an analysis by Decision Resources Group in 2017, more than 40 biosimilars were in clinical development in India, equal those in development in the European Economic Area (EEA), and far more than in development in the United States. Feeling the market robustness many of the Pharma players have jumped already into Biopharmaceutical space, Reliance Life Science being the leader with as many as 14 biosimilar products in their portfolio.
