Biosimilars: Rise In US FDA Approvals Means Lower Or Flat User Fees In FY 2020

01 Aug 2019

Fees for applications and approved products will stay the same, while product development levies will fall 36%, the FDA announces. The agency’s biosimilar activities are becoming more reliant on funding from the growing number of products approved and less on those still in development.

The titan called Atlas is carrying the world on his shoulders. Greek mythotology figure as part of the historical train station roof built in 1888 in Frankfurt, Germany. - Image — Sponsors with approved biosimilars will shoulder more of the burden for funding the agency’s user fee program in FY 2020. • Source: Shutterstock

The maturation of the US Food and Drug Administration’s biosimilars user fee program means the agency can rely more on program fees for approved products, and less on product development fees, in fiscal year 2020.

For biosimilar sponsors, that will translate into a 36% reduction in product development fees in the coming year.