Advocacy for Patient Access to Biosimilars

Monday September 28, 2020

According to a report on biosimilars cost savings in the U.S., biosimilars could lead to over $54 billion in savings over the next ten years, giving 1.2 million patients access to needed medicines and increasing the quality of life for those patients. However, many biosimilars are stuck waiting for market entry after the rigorous FDA approval process, leaving patients in the lurch and billions of dollars at stake. The Biosimilars Council has identified the issues that stand in the way of patient access to these medicines.

Patent Abuses

Biosimilar developers must combat several obstacles in bringing a product to market. Brand companies often create these obstacles to thwart competition and keep biosimilars off the market. These activities, which include patent abuses, limit the ability of biosimilars to reach the market in a timely manner and ultimately hurt patients.

Brand-name biologics are the most significant driver of prescription drug spending in the United States. Since 2014, brand-name biologic drugs have accounted for more than 90 percent of prescription drug spending growth. They now account for 47 percent of total prescription drug spending. This burden is disproportionally shouldered by taxpayers and the federal government. Patients are paying more for their medicines even when lower-priced FDA-approved generics and biosimilars are available.

These lost savings could be used more efficiently to promote better patient care and advances in health care innovation, as well as used to lower health care costs. Additionally, given these barriers, incentives are needed to ensure this innovative class of medicine flourishes. Policymakers must take steps to ensure the viability of this market for America’s patients. Without competition from biosimilars, brand-name biologics will continue to drive up prescription drug spending at an unsustainable rate and keep life-altering treatment out of the hands of patients.

Medicare Part B Proposal

Under current Medicare Part B payment rules, providers have limited direct financial incentives to prescribe biosimilars over reference biologic products. The current payment structure does not support the Administration’s stated goal of ensuring a sustainable biosimilars market that leads to reduced costs and more innovation. To align both Medicare Part B programmatic savings and biosimilar market development, providers in Medicare Part B should be permitted to share in the savings generated from using more competitively priced biosimilar products (compared to the reference biologic), as both an incentive towards biosimilar utilization and a way to drive Medicare Part B programmatic savings.

Misinformation Campaigns

As the biosimilars market begins to expand patient access to critical but costly biological medicines in the United States, misinformation campaigns threaten to slow biosimilar uptake and undermine confidence in these U.S. FDA-approved products. These campaigns, often driven or silently funded by brand manufacturers, are intended to sow doubt among patients and prescribers regarding biosimilars’ safety and efficacy, and to construct regulatory, policy and legal roadblocks to competition. Misinformation threatens the health of the very patients who stand to benefit most from greater access to these treatments.

The Biosimilars Council is committed to working with regulators to create policies that fairly encourage and protect innovation while ensuring all patients have access to the treatment options they need. By increasing our voice in today’s biosimilars narrative and advocating for issues that create incentives for increased biosimilars development and adoption, millions of Americans can experience healthier lives.

To learn more about biosimilars, stay tuned to our blog for updates, or check out our Biosimilars Handbook.

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.