Skinny labels allow quicker market entry of generic and biosimilar competition, reducing prices across the healthcare landscape
WASHINGTON (December 19, 2024) — Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars. Today, the Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, applauds and supports S. 5573, The Skinny Labels, Big Savings Act. S. 5573 provides a safe harbor for skinny labeling, propelling patient access to lower-cost generic medications and protecting the overall health care system. AAM thanks Senators Hickenlooper, Cotton, Welch, and Collins, for their commitment and dedication to patients—especially as skinny label generics decrease the cost of a given drug across branded and generics by 98 percent, on average.
“This legislation is imperative for U.S. patients,” said John Murphy, III, President & CEO for AAM. “When generic medicines become available, they bring immediately lower prices for lifesaving and lifechanging medications. We are thankful for the work done thus far by Senators Welch, Cotton, Collins, and Hickenlooper; and our association greatly appreciates the efforts of the Senate to expedite access to generic and biosimilar medicines by protecting skinny labeling.”
A skinny label is a pivotal mechanism designed to support timely market entry of a generic drug or biosimilar for an indication that is no longer protected by patents. The Hatch-Waxman Act and the Biologics Price Competition and Innovation Act created abbreviated pathways for generics and biosimilars, respectively, to seek timely FDA approval by carving out patented indications from their labels. This approach, which has been effectively used for decades, enables generic and biosimilar manufacturers to enhance competition and broaden patient access to essential medications across different health conditions.
According to the AJMC, from 2015 to 2020, 15 skinny labels alone generated $14.6 Billion in Medicare savings. Without explicit protection for carve-outs, the existence of a single, indication-specific patent could block generic and biosimilar versions from entering the market. S. 5573, The Skinny Labels, Big Savings Act—which was part of the Food and Drug Administration’s FY2024 budget proposal—would reverse a mistaken decision by the U.S. Court of Appeals for the Federal Circuit which, according to the federal government, “threatens significant harm to competition and to consumers.”
MEDIA CONTACT:
Brian Hart
media@accessiblemeds.org
202-249-7112
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 17.5 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.
