Economic barriers, along with regulatory complexity and uncertainty, are shaping the biosimilars industry into something entirely different from the generic small molecule pharmaceutical industry. The sharp demarcation between branded and generic small molecule pharmaceutical companies may not exist in the biologics context. The emerging biosimilars industry may present opportunities for both pioneering and follow-on companies. The regulations, both in the United States and Europe, are still in a very early, formative stage. This presents an opportunity for commentary and an exploration of comparative advantage. This article presents an overview of the US and EU biosimilars regulations, in order to help legal and executive decision makers at biopharmaceutical companies begin to think about the range of expenditures that may be necessary for approval of a biosimilar.

At the end of March 2010 the United States enacted the Biologics Price Competition and Innovation Act (BPCI), the long awaited US pathway to biosimilars. Europe has had an established pathway for biosimilars since 2005. FDA has indicated it will seek to learn from the European experience with biosimilars as it promulgates regulations pursuant to BPCI. This article will explore the basics of the BPCI, compare and contrast it with the European approach, and suggest some possible near and medium turn scenarios for biosimilars in the United States.