Biosimilars in North America

ABSTRACT The United States (US) is the world leader in the development of biopharmaceutical products. These new drugs, numbering about 200, are now losing patent protection and imitators are entering the market of comparable drugs, called biosimilars. According to a popular belief, these producers of biosimilars (erroneously called copycats) are everywhere, except in the United States. In North America, on both sides of the US border, the increase in the number of biosimilar producers is evident. In addition, although the US federal government tries to erect barriers against the entry of foreign-made biosimilars in the country, many states are lobbying the federal government and allowing the use of biosimilars. And biosimilars represent a very convenient ladder for emergent and industrial countries to learn the enigmatic routines of the pharmaceutical industry. Where this segment of the industry will be located is another matter.