White Paper (Part 1) Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America's Patients

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.

Read White Paper Part 1 


Association for Accessible Medicines


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