Economics as a Guide to Developing Public Policies for Biosimilar Pharmaceutical Products
1 November 2012
By Dr. Richard Rozek
Throughout the world, public policies are evolving with regard to biosimilar (large molecule) pharmaceutical products. The associated issues involve a number of scientific, political, legal, and economic questions. In this article from the Queen Mary Journal of Intellectual Property, NERA Special Consultant Dr. Richard Rozek examines the state of the economic debate in the US as the US Food and Drug Administration (FDA) formulates its process for biosimilar products. The draft guidelines issued by the FDA in February 2012 are not specific about whether clinical trials will be required for biosimilar products, whether a given biosimilar product will have the same nonproprietary name as the associated innovator product, or whether a given biosimilar product will be interchangeable as opposed to substantially similar to the associated innovator product. From an economic perspective, biosimilar products differ from generic versions of small molecule pharmaceutical products. Dr. Rozek highlights some of the relevant differences that may help in resolving the issues with the draft FDA guidelines and other public policy questions.
