Biosimilars Forum, Biosimilars Council urge Congressional action on biosimilars
Juliana Reed, executive director of the Biosimilars Forum, released a statement after the House Ways and Means Health Subcommittee hearing on April 8, entitled, “Lowering Costs for Patients: The Health of the Biosimilar Market.”
Reed said, "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."
Reed continued, “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.
Reed noted in her statement that the first biosimilar was approved in 2015 by the U.S. Food and Drug Administration. 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.
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Reed also pointed out that 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," Reed said.
Reed also emphasized in her statement that 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," she said.
Reed continued, "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.
[Read more: AAM report: Generics, biosimilars generate $445B in savings]
Reed concluded, “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.”
The Biosimilars Council released Congressional testimony provided by Craig Burton, executive director of the Biosimilars Council before the House Ways & Means Health Subcommittee hearing.
“Unfortunately, the long-term sustainability of the biosimilar market is in doubt–a result of the combination of ill-considered government policies as well as abuses by both brand manufacturers and pharmacy benefit managers…,” Burton said
Burton continued, "If nothing changes, patients and the healthcare system will pay the price. A fully competitive biosimilar market could save the U.S. an additional $189 billion over the next decade—but those savings will vanish if biosimilars remain trapped in the void. This isn’t just a theoretical discussion; it’s a crisis that will impact real people: the diabetic patient struggling to afford their insulin, the cancer survivor burdened by high treatment costs, the retiree on a fixed income choosing between life-sustaining medicines and rent."
Burton added, “As the U.S. biosimilars market has evolved over the last decade, challenges and policy priorities have as well. However, one thing remains clear–America’s patients and healthcare system rely on biosimilar medicines. We have the tools to fix this. Now, I implore policymakers to use them. The future of biosimilar competition—and the health of millions of Americans—depends on it.”
This article has been updated.