Biosimilars Forum Urges Congressional Action on Biosimilars

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the House Ways and Means Health Subcommittee hearing on “Lowering Costs for Patients: The Health of the Biosimilar Market.”

“Congress must prioritize the use of safe, effective, and lower-cost biosimilars to address America’s skyrocketing prescription drug costs. President Trump and his administration have a mandate to reign in burdensome bureaucracy to deliver America into a golden age of healthcare affordability, innovation and access. This will benefit American patients, providers, employers, veterans, and more through lower-cost prescription drugs and new life-saving medicines.

“The administration and Congressional leaders must advance policies that support a sustainable and thriving biosimilars market. Biosimilars are a commonsense, bipartisan solution to skyrocketing prescription drug prices. Unfortunately, the biosimilar market is not thriving. In fact, if market dynamics do not significantly change, the long-term market sustainability is in peril, and the cost-savings potential of biosimilars could be lost forever.

“The first biosimilar was approved in 2015 by the U.S. Food and Drug Administration (FDA). 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 $181 billion in the next five years.

“Over the next decade, 118 biologics are expected to lose patent protection, and biosimilars could offer significant cost-savings for each of these. This includes a significant wave of oncology drugs, which could lower costs for cancer patients. Only 12 molecules set to lose patent protection from in the next decade have biosimilars in development as of June 2024, with the remaining 106 biologic patent expiries representing a “biosimilar void.” If all products with a patent expiring in the next 10 years were to have a biosimilar in the pipeline, the U.S. healthcare system could save an additional $189 billion in addition to savings generated by biosimilars already on the market or expected to enter.

“Biosimilars also generate billions in cost-savings for the Medicare program as prices continue to increase for reference biologic drugs. Biologic drugs—some of the most expensive drugs available—are estimated to cost Medicare Part B and its enrollees upwards of $32 billion annually. Making biosimilars more available to the Medicare program has the potential to save billions of dollars each year.

“Congress can make prescriptions more affordable for Americans and eliminate government waste in the American health care system by prioritizing pharmacy benefit manager (PBM) reforms that require transparency, delink PBM fees from WAC, and allow all patients and health plans to easily access biosimilars. It’s unacceptable that PBMs prioritize profits over patients. The GOP-led House Oversight Committee, bipartisan leadership of the Senate Finance Committee and federal regulators at the Federal Trade Commission (FTC) have each separately found that PBMs intentionally misalign incentives to inflate drug prices and deny access to lower-cost drugs to those who want it. Specifically, the FTC in 2025 found that PBMs hiked the prices of specialty drugs by thousands of percent to generate $7.3 billion in revenue—all while American patients suffered and the Medicare budget buckled under skyrocketing costs.

“The Biosimilars Forum supports market competition in the pharmaceutical industry. We stand ready to work with both sides of the aisle and the administration to prioritize American patients and provide more choices for lower-cost drugs.”

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

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