AAM Report: Securing Sustainable Markets

The first in a series of papers, this paper examines the challenges to market sustainability for generic and biosimilar medicines that have cleared the regulatory and patent hurdles to obtain FDA approval and launch into the U.S. market.

Future papers by the Association for Accessible Medicines (AAM) will examine threats to the balance between innovation and competition that drives generic and biosimilar development. This includes maintaining incentives to challenge brand-name drug patents and eliminating abuses of the patent system, as well as regulatory challenges relating to generics and biosimilars approval.

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 20 percent of total drug spending.