Increase Patient Access to Lower-Cost Biosimilar Medicines

Wednesday May 25, 2022

Biosimilars advocacy legislation

In 2010, Congress established the regulatory pathway which ultimately led to the first FDA-approved biosimilar becoming available five years later. Since then, over 30 biosimilars have been approved and over 20 are now available to patients.

Because biosimilars are significantly more affordable than brand-name biologics, their growing accessibility has generated significant savings for patients and the health care system. In fact, biosimilars created more than $12 billion in savings from 2015-2020, and are projected to generate over $130 billion by 2025.

However, market and regulatory barriers are hindering greater biosimilar uptake and adoption, meaning many patients are unnecessarily paying for costlier brand medicines. View this infographic to learn more about three legislative proposals that will reduce barriers and help biosimilars reach their full potential for patients.

To learn more about how you can advocate for biosimilars, visit our advocacy page or make your voice heard by visiting our action center.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a 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, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM 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. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors 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 22 percent of total drug spending. Additional information is available at

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Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.