Allows quicker market entry of generic and biosimilar competition, reducing prices across the healthcare landscape, protecting patient access to affordable medicines
WASHINGTON (December 8, 2025) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, applauds and supports The Skinny Labels, Big Savings Act, which today was introduced in the U.S. House of Representatives. The bill was introduced in the House by Representatives Ben Cline (R-VA) and Zoe Lofgren (D-CA). It was previously introduced in the Senate by Senators Hickenlooper, Cotton, Welch, and Collins.
“Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars annually,” said John Murphy III, President and CEO for the Association of Accessible Medicines. “Without hesitation, AAM applauds and supports legislation that will provide a safe harbor for skinny labeling, accelerating patient access to lower-cost generic medications and protecting our health care system. Thank you to Representatives Cline and Lofgren for their hard work on behalf of patients.”
Patient access to generic and biosimilar medicines has never been more critical. The Skinny Labels, Big Savings Act will ensure that the Hatch-Waxman Act’s longstanding provisions regarding skinny labels are not undermined and that patients can continue to access lower-cost medicines as quickly as possible. Skinny labels allow the generic manufacturer to “carve-out” a brand drug sponsor’s patented methods of use from the generic’s FDA-approved labeling. That carve-out process has served the public interest for over 40 years by increasing access to generic medicines, saving the healthcare system billions of dollars.
Indeed, 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, 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.”
Skinny Labels Save Dollars And Lives by Henry Waxman
AAM Applauds Senate Bill to Protect Patient Access to Affordable Medicines
2025 U.S. Generic & Biosimilar Medicines Savings Report
For media inquiries, contact 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. 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 12 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the 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, government affairs, legal affairs, and regulatory policy. More information is available biosimilarscouncil.org.
