Federal Advocacy

The Issue

Generics and biosimilars—cornerstones of the U.S. healthcare system—have provided a reliable safety net for millions of Americans, ensuring access to vital therapies at the lowest possible cost. Yet, a perfect storm of federal regulatory hurdles, patent abuses, and flawed policies threatens the very foundation of this system.

Generics and biosimilars are essential to the U.S. healthcare system and America’s patients. These medicines account for 90% of prescriptions dispensed in the U.S. but only 13% of total drug spending. Over the past decade, their widespread adoption has saved the healthcare system an astounding $3.1 trillion. This success is not just an economic achievement; it is a lifeline for patients who depend on affordable medicines to manage chronic conditions, treat serious illnesses, and maintain a quality of life.

But this success story is in jeopardy. The overall value of generic sales in the U.S. has declined by $6.4 billion since 2019, despite increased utilization and new product launches.

At The Root of this Crisis Lies a Series of Obstacles

Regulatory Barriers: Outdated and unnecessary FDA requirements delay the development and approval of lower-cost generics and biosimilars.

Patent Abuse: Brand-name drug manufacturers exploit the patent system to extend monopolies well beyond the original patent term, creating “patent thickets” that block generic and biosimilar competition.

Flawed Policies:

Medicare policies and practices by pharmacy benefit managers (PBMs) often reward the use of higher priced, brand-name drugs over lower-cost generics and biosimilars.
Medicaid policies penalize generic products with unpredictable rebates even when there are no price increases.
IRA price controls remove predictability needed to support investment in developing new generic and biosimilar products.

Overall sustainability: Due to a lack of adequate reimbursement, generic medicines are increasingly at risk of shortages. Without systemic reforms to stabilize and incentivize the generic drug supply chain, patients could face dangerous interruptions in their treatment.

Protecting Access

If policymakers must act decisively to address these systemic threats. This requires a comprehensive approach:

Streamline the FDA Processes: Ensuring quicker approvals, while maintaining FDA’s high standard of safety, efficacy, and quality, will increase competition and lower prices.
Curb Patent Abuse: Congress must stop the misuse of the patent system by limiting the number of patents brand-name manufacturers can assert, safeguarding opportunities for procompetitive patent settlements, and preventing anticompetitive practices that delay access to generics and biosimilars.
Stop PBMs and Medicare Policies from Denying Patients Access: Medicare and PBMs must stop prioritizing higher-priced brand-name drugs over generics and biosimilars.
Rollback Harmful Federal Policies: Congress should remove the Medicaid Generics Penalty and update Medicaid inflation penalties on generics to align with those included in the IRA.

Learn More

Press Release: Association for Accessible Medicines 2025 Advocacy Priorities
2025 Advocacy Priorities: Protect and Defend Patient Access: The Advocacy Plan to Safeguard Affordable Generic and Biosimilar Medicines
White Paper: Streamlining the Development of Biosimilar Medicines

Campaign

September 16, 2024
Model B

Increase Competition & Access — Support CREATES Act

2024 AAM U.S. Generic & Biosimilar Medicines Savings Report

In 2023, generic and biosimilar prescription medicines saved $445 billion for the U.S. healthcare system overall, with more than $3 trillion saved in the past 10 years.

Federal Advocacy

The Issue

At The Root of this Crisis Lies a Series of Obstacles

Protecting Access

Learn More

Increase Competition & Access — Support CREATES Act

2024 AAM U.S. Generic & Biosimilar Medicines Savings Report

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