Congress and regulators encouraged to stop patent abuses and streamline approvals
WASHINGTON (September 18, 2024) — The Association for Accessible Medicines and its Biosimilars Council today responded to current discussions over potential savings on GLP-1 class medications.
AAM appreciates Chairman Sanders and his interest in generic competition, and AAM members are committed to increasing patient access through competition, including for GLP-1s as they lose patent protection in the coming years. However, government policies often stand in the way of such competition. Slow approvals of new generics, particularly complex generics, can delay market entry. Brand patent thickets impede new biosimilars and generics. And PBM preferences for high-cost, high-rebate drugs can undermine biosimilar and generic adoption. Further, investment in lower-priced products is threatened by the uncertainty created by a political price setting scheme. Rather than doubling down on government price setting schemes, policymakers should swiftly enact legislation to speed FDA approval of new generics and biosimilars, to prevent patent thickets, and to ensure that PBMs prefer lower-price generics and biosimilars.
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.