Since it was created in 2007, the Food & Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategies (REMS) has been an important tool for patient safety by ensuring that the benefits of a drug or biological product outweigh its safety risks. FDA-mandated REMS serve a clear public health purpose, yet some brand drug companies have been misusing this patient safety program and other restricted access drug programs to extend market monopolies, intentionally limiting patient access to biosimilars. These abuses are growing, resulting in delayed approval of biosimilars, costing patients, the federal government and the health care system billions of dollars.
Biosimilars: Breaking Down Barriers to Patient Access
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.
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 www.accesiblemeds.org.