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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