IP Issues

Roadmaps for Ensuring Patient Access to Generic and Biosimilar Medicines: Securing Sustainable Markets

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.

AAM Statement on Importation Task Force

WASHINGTON DC (July 19, 2018) – Secretary Azar testified on June 26 before the Senate Finance Committee, policy makers should examine whether the U.S. is "underpaying for and under-reimbursing for generics. We need a strong, robust generic market. We may be driving those prices so low that we're creating manufacturing anomalies that lead to sole-source products with others exiting. We need to look at that and be open minded about whether we've actually made it too low."

AAM Files Brief to Oppose Pharmaceutical Company Abuse of the Patent System

WASHINGTON, DC (May 18, 2018) –AAM filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit calling on the court to reject gamesmanship of the patent system which keeps prescription drug prices high for patients. In this case, Allergan Inc. has transferred its patents to the St. Regis Mohawk Native American Tribe with the intent to use the tribe’s sovereign immunity to evade review of the drug company’s patents. AAM is joining with a diverse range of groups, including America’s Health Insurance Plans, in opposing this abuse of the patent system.

AAM Statement on Oil States Energy Services v. Greene's Energy Group

AAM commends the Supreme Court for upholding the constitutionality of the Inter Partes Review (IPR) process. This is a win for patients who depend on continued access to safe, effective and affordable generic and biosimilar medicines. IPR helps enhance patient access to generic and biosimilar medicines by providing a more efficient mechanism for determining whether the patents of brand-name drug manufacturers are valid.

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