Biosimilars Uptake Failure

Monday September 9, 2019

failure to launch white paper

America’s health care system is eager for biosimilars, especially in light of mounting evidence that they deliver increased patient access and savings by providing competition for costly brand-name biologics. Biosimilars are lower-priced versions of brand medicines that have been projected to save as much as $54 billion over the next 10 years for a range of debilitating and life-threatening diseases. Widely available in the European Union and around the globe, and with more than 20 biosimilars now approved by the U.S. Food and Drug Administration (FDA), biosimilars hold the potential to be an integral component of efforts to reduce the high cost of brand-name biologics and enhance patient access to lower-cost treatments.

Unfortunately, significant barriers stand in the way of greater utilization and adoption leaving  America’s patients and payers to lose out. In Part I of this series, “Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America’s Patients,” the Association for Accessible Medicines’ (AAM) Biosimilars Council found that delayed launch of biosimilars due to patent thickets has cost the U.S. health care system an astounding $7.6 billion in lost savings since 2015.

However, savings are also being missed as a result of barriers to adoption. Based on a review of U.S. biosimilar launches, the Biosimilars Council  found that despite significant price discounts, few of the nine biosimilars available to patients has been able to garner significant market share. This is a direct result of anti-competitive market access tactics by brand-name companies, along with inadequate incentives for their use and insufficient information for patients. Taken together, these post-market barriers have slowed biosimilars adoption, adding upwards of $2.2 billion in potential lost savings since 2015 to the $7.6 billion.

In total, brand-name biologic company anti-competitive tactics and perverse market access barriers have cost America’s patients nearly $10 billion since 2015. Patients, taxpayers and the overall health care system are bearing the costs of these tactics.

This white paper will provide an explanation to the perverse mixture of brand-name biologic companies’ anti-competitive market access tactics and inadequate incentives that have cost the U.S. health care system billions of dollars in lost savings.

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 22 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.