Overcoming the Impediments to Biosimilar Adoption in the United States - What Can Be Learned From the Success of Other Countries?

Looking to developed countries with a functioning biosimilars market (to include European Union countries, Australia, Canada, Japan, and Singapore), the project aims to identify and assess biosimilar policy options in other countries that could be implemented in the United States. The project will identify barriers to the U.S. biosimilars market, approaches used by other countries to overcome these barriers that could be applied to the U.S. market, and specific action U.S. policymakers need to take to adopt promising approaches from abroad. The key areas of focus are regulatory and legal methods to establishing similarity, intellectual property barriers, payment frameworks, and perceptions of biosimilar safety and effectiveness. The project will entail an extensive literature review and interviews with experts.