Patent Thickets Bog Down U.S. Biosimilar Launches

Delayed Access to Biosimilars Has Cost the U.S. Health Care System $7.6B Since 2015

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), recently released a white paper finding that delayed biosimilar entries caused by brand-name biologic manufacturer patent accumulation or “thicketing” has cost the U.S. health care system $7.6B since 2015. This includes more than $1.2B in lost savings to the Medicare program.

“Patients rightfully ask ‘where are all of the FDA-approved biosimilars?’ The answer is: stuck in brand manufacturer patent thickets designed to thwart competition and protect monopoly pricing,” says Christine Simmon, Executive Director, Biosimilars Council, and Senior Vice President of Policy and Strategic Alliances, AAM. “Our analysis demonstrates that billions in savings are lost in these brand patent thickets and we urge policymakers to act now to ensure the viability of the biosimilars marketplace so America’s patients can access these medicines.”

Patent “thicketing” occurs when a brand-name pharmaceutical company accumulates dozens of patents near the end of the product lifecycle under the guise of “innovative” processes or development that warrant additional protections. These patent thickets chill competition by discouraging biosimilar competitors from entering a market because of the exorbitant cost and time of litigating meritless patents. These costs are estimated to be roughly $3M per patent. A biosimilar treatment cannot come to market until this litigation has been resolved. Under this scheme, some brand-name pharmaceutical companies prolong a brand-name biologic’s monopoly pricing and delay patient access to more affordable, FDA-approved biosimilar medicines.

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.

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. For more information, visit www.biosimilarscouncil.org.