Insulin Biosimilars White Paper

Thursday May 16, 2019

Insulin has been available to America’s diabetes patients for decades, and millions of patients rely on this medicine every day to control their diseases and maintain their health and quality of life. Yet even as the number of Americans suffering from Type I and Type II diabetes continues to rise, patients are facing increasing difficulties in paying for this life-saving medicine. FDA-approved biosimilar medicines have the potential to make insulin more affordable and accessible to patients. However, realizing the promise of biosimilar insulins requires addressing a series of challenges that threaten their future.

While there remain significant challenges to successful development of a robust biosimilars market in the United States, the good news is that most of these can be surmounted by thoughtful policymaking by FDA, CMS and Congress. Opportunities to foster patient access to biosimilars include addressing brand company spread of misinformation on biosimilar safety and efficacy, aligning payer and provider incentives to encourage early adoption of biosimilars, and ending brand patent-gamesmanship. In particular, policymakers must:

Ensure that rebates and formulary gamesmanship does not prevent patient access to biosimilars that are priced lower than their brand counterparts;

Address over-patenting by brand manufacturers to block biosimilar competition, including by strengthening IPR, increasing patent transparency in the Purple Book, and speeding up the patent dance to help biosimilars get to market; and

Remove regulatory barriers to competition such as the naming of biosimilar products.

The confluence of market-based factors, including rebates and pricing, over-patenting by brand manufacturers, and regulatory mis-steps have created an insulin market which suffers from high prices and a lack of competition. Biosimilar competition offers the promise of significant savings and increased patient access. Policymakers can and should take immediate steps to ensure patient access to lower cost biosimilar insulins.

This paper outlines those challenges and recommends actions for policymakers to foster the development of biosimilar insulins for America’s patients.

Read the White Paper

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 23 percent of total drug spending. Additional information is available at

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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.