FDA Moves to Speed Biosimilar Development, Lower Prescription Drug Costs

If you or a loved one depends on expensive biologic medications for cancer, arthritis, or diabetes, relief could soon be on the way. In a step toward more affordable medications, the U.S. Food and Drug Administration (FDA) announced new measures to speed up and lower the cost of developing biosimilars, the lower-cost alternatives to brand-name biologic drugs.

Biosimilars work the same way as their original biologics but have traditionally faced long, expensive approval processes. The FDA’s new draft guidance, released October 29, 2025, streamlines that pathway by removing redundant clinical testing requirements and allowing developers to rely more on advanced analytical studies.

Cutting Costs Without Cutting Corners

Biologic medications account for only 5 percent of U.S. prescriptions but make up more than half of total drug spending, according to 2024 data. Although the FDA has approved 76 biosimilars to date, they represent less than 20 percent of the U.S. biologics market.

By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10 percent of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.

Today’s announcement furthers President Trump’s directive to lower drug prices for the American people. Biologics treat many chronic diseases, but for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars. — Health and Human Services Secretary Robert F. Kennedy Jr.

FDA Commissioner Dr. Marty Makary added that reducing unnecessary testing will make lifesaving treatments more affordable and accessible.

By streamlining the biosimilar development process and advancing interchangeability, we can achieve massive cost reductions for advanced treatments that millions of Americans depend on. — FDA Commissioner Dr. Marty Makary.

What the New Guidance Does

The new draft guidance—Scientific Considerations in Demonstrating Biosimilarity to a Reference Product—marks a shift in how the FDA evaluates biosimilar products.

Previously, developers were often required to run costly comparative clinical studies lasting up to three years and costing roughly $24 million per drug.

Under the updated approach, those studies will no longer be required when other scientific data, such as analytical testing, sufficiently demonstrate similarity. The FDA also clarified that “switching studies,” sometimes used to prove that patients can safely move between brand-name biologics and biosimilars, are no longer recommended.

These changes aim to make biosimilars more comparable to generic drugs in both the speed and affordability of approval, without compromising safety or effectiveness.

Why it Matters for Patients and Families

For patients living with cancer, autoimmune diseases, or diabetes, biologic drugs can cost thousands of dollars per dose. Wider adoption of biosimilars could mean significant savings for both families and the healthcare system.

Many of these conditions can lead to additional complications and the need for expensive long-term care. Lower drug costs can help.

Science continues to evolve, and the FDA remains committed to advancing common-sense policies that promote efficient and effective biosimilar development. — Dr. George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research.

Lower-cost biosimilars can also reduce long-term financial strain, helping families preserve retirement savings or pay for other healthcare needs. As biologics continue to dominate treatment for chronic and age-related illnesses, affordability has become central to both public health and long-term care planning.

A Broader Push for Competition

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 created the pathway for biosimilar approval. Still, only a fraction of biologics losing patent protection have biosimilar versions in development. The FDA hopes its new framework will change that.

With biologics accounting for over $260 billion in U.S. spending annually, expanding access to biosimilars could be one of the most powerful tools for controlling future healthcare costs.

Planning for the Future

High prescription costs often factor into the financial impact of long-term care, especially when chronic conditions require ongoing treatment. By promoting competition in the biologic drug market, the FDA’s new policy could help you better manage medical expenses while planning for long-term care or retirement.