Biosimilar Red Tape Elimination Act and Medication Affordability and Patent Integrity Act address longstanding barriers inhibiting patient access to lower-cost prescription options
WASHINGTON (June 17, 2026) — Today, alongside its Biosimilars Council, the Association for Accessible Medicines applauds the positive momentum for America’s patients, as the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act both pass out of the Senate HELP Committee.
Separate statutory requirements for interchangeability impose unnecessary development costs, creates confusion among healthcare stakeholders, and may discourage competition without improving patient outcomes. The Biosimilar Red Tape Elimination Act will clear up confusion, streamline the approval process, and get critical—and lower cost—medicines to patients faster.
“Working to modernize the biosimilar approval framework by eliminating outdated and unnecessary statutory requirements related to interchangeability is imperative to patient access and affordable care,” said Alex Keeton, Executive Director for the Biosimilars Council.
The Medication Affordability and Patent Integrity Act would improve transparency and coordination between the Food and Drug Administration and the United States Patent and Trademark Office while strengthening the integrity of the pharmaceutical patent system.
“For generic and biosimilar manufacturers, a predictable and transparent patent system is essential to bringing more lower-cost medicine options to families and individuals in the U.S. Greater consistency and transparency between the FDA and USPTO offers stakeholders increased certainty—and that leads to a more resilient supply chain, not only better supporting patients, but also better supporting the entire healthcare system,” said John Murphy III, President and CEO for the Association for Accessible Medicines.
Since biosimilars entered the U.S. market in 2015, they have generated savings of more than $56 billion and have been used in more than 3.3 billion days of patient therapy with no clinically meaningful differences in patient safety or outcomes. Together, in the past decade, generic and biosimilar medicines have saved the U.S. healthcare system $467 billion.
With thanks to the Senate HELP Committee, AAM urges policymakers to remain focused on bills that serve the best interest of American patients. The Ensuring Timely Access to Generics Act of 2025 will strengthen oversight of the FDA citizen petition process and help prevent its misuse as a tool to delay generic competition. This bill, S. 3014, which did not move out of committee today, should continue to be prioritized.
AAM, the Biosimilars Council, and 3 Dozen Groups Support the Biosimilar Red Tape Act
U.S. Generic & Biosimilar Medicines Savings Report
Media contact: media@accessiblemeds.org
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 12 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available at www.biosimilarscouncil.org.
