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Washington – The Association for Accessible Medicines has announced its 2025 advocacy priorities, focusing on safeguarding patient access to affordable generic and biosimilar medicines amid growing systemic challenges. Generics and biosimilars account for 90% of prescriptions dispensed in the U.S. but only 13% of total drug spending. These medicines have saved the healthcare system $3.1 trillion over the past decade. However, regulatory barriers, patent abuses, and flawed policies now threaten their sustainability, putting millions of patients at risk.
In a statement, AAM highlighted the urgent need for policy reforms to address the decline in generic sales, which have dropped by $6.4 billion since 2019 despite increased utilization. The organization warned that without action, patients could face higher costs, reduced access, and dangerous shortages of essential medicines.
Key advocacy priorities for 2025
AAM’s 2025 priorities focus on four critical areas to protect and strengthen the generic and biosimilar market:
- Streamlining FDA approval processes: AAM is calling for the elimination of outdated and unnecessary FDA requirements, such as redundant clinical efficacy studies for biosimilars, which delay approvals and stifle competition. The organization advocates for streamlined processes, including the use of global comparators and updated legislation to expedite approvals while maintaining safety and efficacy standards.
- Curbing patent abuse: AAM is urging Congress to address brand-name drug manufacturers' misuse of the patent system. The organization seeks to limit the number of patents that can be asserted, prevent anticompetitive practices, and ensure timely access to affordable generics and biosimilars.
- Reforming PBM and Medicare policies: AAM is pushing for reforms to ensure that pharmacy benefit managers and Medicare prioritize lower-cost generics and biosimilars over higher-priced brand-name drugs. The organization is advocating for greater transparency in PBM practices and the delinking of PBM fees from drug list prices to reduce patient costs.
- Rolling rack harmful federal policies: AAM calls for removing Medicaid penalties on generics and refining Inflation Reduction Act (IRA) price controls to support competition. The organization also seeks to address policies that create unpredictability for generic and biosimilar manufacturers, such as the “bona fide marketing” standard and the IRA’s “valley of death” for biosimilars.

A call to action for policymakers
AAM emphasized that the stakes are high, with millions of Americans depending on affordable generics and biosimilars to manage chronic conditions, treat serious illnesses, and maintain their quality of life. “This is not just about dollars and cents—it is about lives,” said AAM President Dan Leonard. “Policymakers must act swiftly to protect this system and ensure patients are not forced to choose between their health and financial security.”
The organization’s advocacy priorities come at a critical time, as patients and healthcare providers increasingly face the consequences of a strained generic drug supply chain, including shortages and rising costs. AAM’s plan aims to stabilize the market, promote competition, and ensure that the promise of affordable, life-saving medicines remains a reality for all Americans.
As the 2025 policy debates approach, AAM is calling on Congress, the Administration, and stakeholders to prioritize reforms that protect patient access and uphold the integrity of the U.S. healthcare system.