The Biosimilars Forum To Provide Comment at FDA’s Annual Meeting on the Biosimilar User Fee Program

Washington D.C. — Today, the U.S. Food and Drug Administration (FDA) is hosting its annual meeting to review the financial management of multiple user fee programs, including the Biosimilar User Fee Act (BsUFA) II. 

Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), which provides a streamlined pathway for FDA review and approval of biosimilars, 27 biosimilars have successfully been approved and 17 are now on the market. While approvals have accelerated in recent years, there continues to be inequitable access to and slow usage of these safe, effective lower-cost treatment options. 

One contributing factor that the FDA will discuss today is the uncertainty about the financial stability of the BsUFA program. 

Juliana Reed, President of the Biosimilars Forum, released the following statement: 

The Biosimilars Forum congratulates the FDA for the very positive evaluation by the Alliance to Modernize Healthcare, or Health FFRDC, which in its report recognized that FDA has effectively managed resources for the user fee programs. 

At the annual meeting, the Forum will highlight two key areas in the Health FFRDC’s report not mentioned in FDA’s biosimilars plan, which we believe are important for the fiscal management of the BSUFA program: 1) a robust, standardized carryover policy and standard operating procedure for managing prior year funds, and; 2) a cross-FDA focus group to evaluate the trigger management process.

We appreciate the FDA’s work on this issue to date and look forward to the continued dialogue to ensure an efficient biosimilar development process that leads to more prescribers and patients using these lower-cost therapies.

To read the Biosimilars Forum’s comment that will be submitted to the FDA click here. For more information about biosimilars and the Biosimilars Forum, please visit or