The Biosimilars Action Plan:Promoting Faster and More Extensive Adoption of Biosimilar Drugs

摘要

The pace with which biosimilar drugs have been adopted in the United States has frustrated (and displeased) policymakers (1). After passage of the Biologies Price Competition and Innovation Act (BPCIA) (2) as part of the Affordable Care Act of 2010 (3), policymakers intended and expected significant reductions in expenditures for this class of biopharmaceuticals (4). The Federal Trade Commission (FTC) had predicted that the percentage of savings would be lower than that of the <90% reduction in costsfor small-molecule generic drugs (5,6). That this has not been the case provides the policy motivation for a joint effort by the Food and Drug Administration (FDA) and the FTC to achieve that goal.