Drug companies could face new penalties for settlement deals that delay cheaper generic or biosimilar drugs. The FTC could sue, and some first generic companies could lose their 180-day exclusivity if they violate the rule.
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Preserve Access to Affordable Generics and Biosimilars Act is a Senate bill waiting for floor action. The latest recorded action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
Latest action on S. 1096: Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
Who this affects: This bill mainly affects brand-name drug makers, generic drug companies, and biosimilar companies because it changes what they can agree to when settling patent fights. It also affects the FTC and the Department of Justice, which would get more filings and more enforcement power. Patients, insurers, and government health programs could be affected if the bill changes how fast lower-cost drugs reach the market.
Why this matters: This bill matters because delayed generic and biosimilar competition can keep drug prices higher for longer. The bill tries to stop settlement deals that may slow down cheaper alternatives. That could help some patients, insurers, and public programs pay less for medicine if more lower-cost products reach the market sooner. At the same time, the bill raises the legal risk of settling patent disputes, so it could change how drug companies fight, settle, and structure these agreements.
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