In an article in the New England Journal of Medicine, Dr. Richard G. Frank writes that the Biologics Price Competition and Innovation Act adopted in 2010 was intended to check the price increase of biologic drugs and increase the speed of biosimilars being introduced to the marketplace.
Unfortunately, according to Dr. Frank, the law failed to live up to its promise as a number of factors (names and labels of biosimilars, interchangeability, payment arrangements, secret manufacturing processes) have together slowed the development of biologics competition. The FDA, he notes, wants to increase the development of biosimilar competition. It is estimated $105.5 billion was spent on biologic drugs in 2016 – and growth in spending has been averaging about 10 percent each year. Frank concludes, “Thus, competition creates the potential for considerable savings — but if the impediments continue, important savings will probably be left on the table.”
Read the article on biosimilars by Dr. Frank in NEJM.