The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.

India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.