FDA's Biosimilar Program Cost Nearly Double The User Fees Collected

The overall cost of FDA's biosimilar program for its first three years was nearly double the amount the agency collected in user fees between fiscal year 2013 and 2015. The final results of an FDA study on the workload and cost of the biosimilar review program found the program cost $81.7 million in its first three years, while FDA drug center chief Janet Woodcock told lawmakers last month that the center had collected around $42.8 million in user fees during...