AAM praises Senate committee approval of biosimilar and patent reform bills

WASHINGTON — The Association for Accessible Medicines (AAM) and its Biosimilars Council welcomed the Senate Health, Education, Labor and Pensions (HELP) Committee's action, which advanced two pieces of legislation to reduce barriers to lower-cost medicines and improve pharmaceutical patent transparency.

The committee approved the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act, measures AAM said would accelerate patient access to more affordable prescription drugs and strengthen competition in the pharmaceutical marketplace.

The Biosimilar Red Tape Elimination Act would eliminate separate statutory requirements for biosimilar interchangeability, which AAM argues create unnecessary development costs, cause confusion among healthcare stakeholders, and may discourage competition without improving patient outcomes. The organization said the legislation would streamline the approval process and help bring lower-cost medicines to market more quickly.

“Working to modernize the biosimilar approval framework by eliminating outdated and unnecessary statutory requirements related to interchangeability is imperative to patient access and affordable care,” said Alex Keeton, executive director of the Biosimilars Council.

The Medication Affordability and Patent Integrity Act aims to improve transparency and coordination between the FDA and the U.S. 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 of AAM.

According to AAM, biosimilars have generated more than $56 billion in savings since entering the U.S. market in 2015 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, generic and biosimilar medicines have saved the U.S. healthcare system $467 billion over the past decade.

AAM thanked members of the Senate HELP Committee for advancing the legislation and urged policymakers to continue focusing on measures to expand patient access to affordable medicines. The organization specifically called for continued consideration of the Ensuring Timely Access to Generics Act of 2025 (S. 3014), which would strengthen oversight of the FDA's citizen petition process and help prevent its misuse to delay generic competition. The bill did not advance from committee during the latest session.