Bipartisan Legislation Targets Patent Thickets, Supports Biosimilars Uptake

The Biologic Patent Transparency Act, introduced in March and sponsored by Senators Susan Collins (R-ME) and Tim Kaine (D-VA), would require biologic manufacturers to submit and publicly list patents in the FDA Purple Book, the agency’s publicly available listing of biological products. Biosimilars Council Executive Director Christine Simmon, spoke with the National Journal about the potential benefits of this proposal:

Christine Simmon, executive director of the Association for Accessible Medicines Biosimilars Council, said the legislation could end up saving drugmakers money by removing the need to independently investigate and discover patents on a biologic drug.

“There are 18 biosimilars approved; there’s only seven on the market,” Simmon said. “Most of the biosimilars that have ‘failed to launch’ have been due to patent litigation and other patent-related issues.”

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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 on our about page.

About AAM

AAM 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 and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors 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 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.