Biosimilars Forum Supports the Negotiated BsUFA III Agreement in Capitol Hill Testimony

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after providing testimony on the Biosimilar User Fee Act (BsUFA) III commitment letter before the Health Subcommittee of the House Energy and Commerce Committee:

“The Biosimilars Forum supports the negotiated BsUFA III agreement, and we believe it represents important progress to help ensure biosimilars are available more quickly for patients that need them. We are pleased the commitment letter codifies review timelines for labeling supplements, provides meeting management enhancements, and promotes best practices of communication between FDA and sponsors.”

“The Biosimilars Forum looks forward to working with the FDA to help implement the guidances within the BsUFA III commitment letter. We expect conversations to continue about the necessity for virtual inspections because the industry needs an established review process that can be implemented when in-person inspections are not possible.”

The Biosimilars Forum is a nonprofit organization working to advance biosimilars in the United States with the goals of expanding access and availability and improving healthcare outcomes. Since its inception, the Forum has worked to expand the uptake of biosimilars throughout the healthcare system through policies that will increase access for patients and lower costs through increased competition. Forum members represent companies with the most significant U.S. biosimilars development portfolios.

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.