Biosimilars Forum Supports the FDA, Its Employees, and Its Mission

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement about the U.S. Food and Drug Administration (FDA) and its recent loss of institutional knowledge and expertise through reductions in force.

“A well-resourced and stable FDA is necessary to ensure that Americans have access to safe and effective medicines, like lower-cost biosimilars. The Biosimilars Forum is concerned that reductions in critical FDA personnel risk losing the institutional knowledge and expertise needed to fulfill the agency’s mission. The reductions in force at the FDA —and the loss of the qualified and dedicated staff who fulfill its mission—risk harming Americans that need healthcare.

“Americans are healthier and have more access to lower-cost medicines because of the FDA’s efforts. The FDA was instrumental in creating the framework for lower-cost biosimilars. Fifteen years ago, Congress passed the landmark Biologics Price Competition and Innovation Act (BPCIA) to pave the way for biosimilars to lower drug costs for Americans. Since then, the FDA has approved more than 70 biosimilars, which have saved the U.S. healthcare system $56 billion, with the potential to save an additional $189 billion in the next five years. The biosimilars industry and the cost-savings it creates would not exist without the support of Congress and the FDA.

“The critical FDA staff who are involved in reviewing and approving biosimilars are role models of efficiencies and effectiveness. With the inception of the BPCIA, the FDA team helped create an entirely new industry from the ground up to provide Americans with improved access with safe and lower-cost medicines. Their work have been commendable and important.

“The Biosimilars Forum and our members are committed to working with Commissioner Makary, Congress, and our nation’s healthcare agencies to ensure the FDA remains well-equipped to fulfill its mission. We stand ready to work with the Administration to improve patient outcomes and increase medication access and affordability.

“Biosimilars generate billions in cost-savings in the Medicare program as prices continue to increase for reference biologic drugs. In fact, these medications were 46% of U.S. prescription drug spending in 2022, despite only making up 3% of prescriptions. Americans spent $568 billion on pharmaceuticals in 2022 with $260 billion going toward biologics.

“There is a major void of biosimilars in the pipeline, even with these significant cost-savings. Of the 118 biologics set to lose patent protection in the next decade, only 10% of these have biosimilars in development. This biosimilar void threatens to leave patients without affordable alternatives to their chronic health conditions, forcing them to rely on high-cost brand-name drugs.

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

+++

MEDIA CONTACT:

Scott Lusk

Signal Group, EVP

202-288-3233; slusk@signaldc.com