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The Indian generics industry got its first big break in 1984, when the US passed what is known as the Hatch-Waxman Act. With this legislation, the US streamlined the generic approvals, thereby making it easier for generic companies to compete in the US drug market. Observers of the pharmaceutical industry consider today's opportunity for India in biosimilars as not being different from that of the generics industry in 1984
Major countries around the world are now inclined to allow biosimilars. The Indian biogenerics industry is poised to exploit the opportunity they did in the case of generics, although it has no clear advantage at the moment. "Natural advantage is created over time," says Arun Chandavarkar, CEO of Biocon. Industry leaders think that the right policies and investments can create an advantage over the next decade.

Industry Has Come a Long Way A biosimilar is a molecule that is close in structure and function to a biological drug. Small molecules are easy to make and characterise. Since the precise nature and function of biologicals are difficult to understand, it is hard to establish that two products are exactly the same. So, making a biosimilar is not as easy as making a generic small molecule, which is why we need to use a different measuring stick to estimate the potential of Indian i ..
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