Data exclusivity

If companies want to enter the US market, they will come across the barrier of exclusivity.

I am not sure which way the wind will finally blow, but currently the debate forbids biosimilar companies to file an application for 4 years from the date of filing of an innovator product. Also, the innovator company gets 12 years of protection only after which any biosimilar product will receive an approval (if its worthy). Over and above that, the innovator can get extensions in exclusivity for another 12 years if it modifies its products reasonably.

However, if the biosimilar company relies on its own data completely to develop its biosimilar product, then it can circumnavigate the 12 year restriction mentioned above. Maybe that is the ploy of companies like DRL which are generating tonnes of data from emerging markets which can be used to file when the patent expiration of the innovator therapies occur in the US.