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. It is the first in a series of AAM papers that will highlight challenges to the overall sustainability of the generics and biosimilars industry. Future papers will examine threats to the balance between innovation and competition that drives generic and biosimilar development, including 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.
