Congress encouraged to stop patent abuses and eliminate biosimilar misinformation
WASHINGTON (September 24, 2024) — On the anniversary of the enactment of the Hatch-Waxman Act forty years ago today, the Association for Accessible Medicines and its Biosimilars Council today commended the slated mark up by the Senate Health, Education, Labor and Pensions Committee of two important pieces of legislation – the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act. AAM urges Congress to swiftly pass both pieces of legislation.
“Forty years ago today, the Hatch-Waxman Act ushered in trillions in savings for patients through generic medicines,” said David Gaugh, Interim President and CEO of AAM. “AAM commends the Senate HELP Committee for continuing work to bring generic medicines and biosimilars to patients. These two bills will help ensure generic and biosimilar savings for the next 40 years.”
The Biosimilar Red Tape Elimination Act is consistent with the FDA’s recommendation to remove the statutory distinction between biosimilars and interchangeable biologics. This distinction, which is not based on any scientific differences between the products, has resulted in brand misinformation, patient and provider confusion, and ultimately, hindered biosimilar adoption. Of note, FDA has emphasized that there is no scientific difference between biosimilars and interchangeable biologics through numerous educational offerings for providers and patients, including a recent article published in JAMA. No other country in the world uses this arbitrary designation.
The Medication Affordability and Patent Integrity Act would require the sponsor of any application, including any drug or biologic application, to certify to both the FDA and PTO that information submitted to each agency is consistent with information submitted to the other. This clarification will help address gaming of the patent system by brand drug manufacturers.
For media inquiries, contact the Communications department at media@accessiblemeds.org.
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, 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 of finished generic pharmaceuticals and biosimilars, manufacturers 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 13.1 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.