Skinny Labels are vital for U.S. patient affordability; Calls on Congress to act
WASHINGTON (June 3, 2026) — The Association for Accessible Medicines commented on today’s unanimous 9-0 decision in Hikma vs. Amarin in support of the defendant Hikma, a generic medicines manufacturer and AAM member. The case focused on skinny labels, a pathway codified in law in Hatch-Waxman, for generic medicine development for specific indications, bringing lower-cost medicines to patients sooner. Brand medicine companies often apply for additional patents to extend their exclusivity and litigate legal efforts to develop generic versions of the original patented medicine once the initial patent expires.
“The Supreme Court’s unanimous decision in Hikma v. Amarin reinforces Congress’s intent to balance innovation with affordable access by enabling lower-cost generics and biosimilars to reach patients through skinny labels that respect valid later-approved innovative patents.
“Too often, brand manufacturers exploit the patent system to delay competition through repeated litigation—leaving patients to pay the price.
“The Court’s decision affirms that skinny-label pathways are a vital part of the U.S. drug system. Now Congress should remove any remaining uncertainty by passing the Skinny Labels Big Savings Act, ensuring affordable medicines can reach patients without unnecessary legal barriers—just as Congress intended.”
U.S. Generic & Biosimilar Medicines Savings Report
Media 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 at www.biosimilarscouncil.org.
