The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions

Legislative proposals to create an expedited pathway for review of follow-on biologic drugs (“FOBs”; also called biosimilars) have generated much debate about potential cost savings, with estimates of federal budget savings over ten years of $3.6 to $14.1 billion.

This very broad range reflects substantial uncertainty about a number of critical assumptions underlying such forecasts, and policymakers should therefore proceed cautiously in assessing the potential impacts of legislation establishing an expedited pathway for FOBs.

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