BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA); Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017"

BIO generally supports and agrees with FDA's statements that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the 351(k) pathway also presents unique challenges compared to existing programs. The comments provide specific details around FDA's proposed principles for development of a biosimilars user fee program as well as FDA's proposed structure and fees.