Patent Abuse Blocks Access to Biosimilars for Patients

Tuesday June 25, 2019

As prescription drug costs continue to increase, biosimilar medicines represent hope for patients seeking access to more affordable treatment. Biosimilars are lower-priced versions of brand medicines used to treat debilitating and life-threatening diseases, such as Crohn’s disease, ulcerative colitis, cancer and psoriatic arthritis. Patients and physicians can rely on FDA-approved biosimilar medicines just as they would the brand-name product. Widely available in the European Union and around the globe, they are an integral component of efforts to reduce the high cost of brand-name biologics and enhance patient access to lower-cost treatments.

Unfortunately, many biosimilar medicines are not available to patients even after they have successfully navigated the stringent regulatory process to obtain FDA approval. In fact, although 20 biosimilars have been approved by the FDA, only seven are currently commercially available. This is a direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies beyond the period Congress deemed reasonable.

Patients, taxpayers and the overall health care system are bearing the costs of these patent schemes and delayed access to biosimilars. In this analysis, the Association for Accessible Medicines (AAM) Biosimilars Council found that delayed entry of biosimilars due to patenting has cost the U.S. health care system an astounding $7.6 billion in lost savings since 2015.

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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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