White Papers Find Multiple Reasons for Delayed U.S. Biosimilars Launch and Adoption

September 23, 2019

Biosimilars Team

Although more than 20 biosimilars have been approved by the U.S. Food and Drug Administration since 2015, fewer than half are commercially available. A series of white papers from the Biosimilars Council—a division of the Association for Accessible Medicines (AAM)— explores possible reasons for the delay.

Part 1 of the series—“Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America’s Patients”—addresses the concept of patent “thickets”: multiple patents accumulated near the end of a product lifecycle for processes or development that warrant additional protections. According to the Biosimilars Council, these patent thickets discourage biosimilar competitors from entering a market because of the exorbitant cost and time associated with litigating patents. (A biosimilar treatment cannot come to market until patent litigation has been resolved.) The analysis estimates that patent thicketing has cost the U.S. health care system $7.6 billion since 2015, including more than $1.2 billion in lost savings to the Medicare program.

Part 2 of the series—“Failure to Launch: Barriers to Biosimilar Market Adoption”—posits that anti-competitive market access tactics by brand-name companies, together with inadequate incentives for biosimilar use and insufficient information for patients, have prevented the biosimilars market from taking hold in the United States. The result, according to the white paper, has been an additional $2.2 billion in lost savings for the U.S. health care system.

The white papers are available for download from the Biosimilars Council website.