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.
Generic and biosimilar medicines are a proven solution to lowering drug costs, and the use of these medicines saved more than $313 billion in 2019 alone. At a time of high economic insecurity, access to more-affordable generic and biosimilars means patients are more likely to fill and use a generic drug prescription.
WASHINGTON, DC (March 18, 2019) – Karin Hessler joins the Association for Accessible Medicines as Assistant General Counsel, effective today.
WASHINGTON, DC (February 13, 2019) — With everyone from patients to the President demanding action on drug pricing, AAM welcomes the re-introduction of the Preserving Access to Cost Effective Drugs (PACED) Act.
WASHINGTON, DC (October 17, 2018)–Yesterday the Association for Accessible Medicines (AAM) filed an amicus brief in the Supreme Court case Helsinn v. Teva calling on the court to reject one form of patent system manipulation attempted by a brand-name drug company. The case will be heard on December 4.
New report provides further evidence of patent abuse
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."
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 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.
Prescription drugs treat conditions and improve patient health. But when drug prices are too high, access to medicines becomes out of reach for far too many patients.
Share the infographic below to help educate lawmakers on how generic and biosimilar medicines are the remedy to high drug costs.