WASHINGTON, DC (February 7, 2019) —Generic and biosimilar manufacturers rely on FDA approval to operate their businesses—but the Hatch-Waxman Integrity Act requires that to get it, they must surrender their right to question the validity of suspect drug patents. The Administration and Congress have been vocal about enhancing generic and biosimilar competition to lower prescription drug prices. Blocking tools to combat pharmaceutical company abuses of the patent system keeps drug prices high for patients and taxpayers. Congress should reject this misguided legislation.
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.
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 at www.biosimilarscouncil.org.