A bill to amend title XI of the Social Security Act to alter when biosimilar biological products are eligible for price negotiations under the Medicare program.
About This Bill
Committee
Latest Action · December 9, 2024
Read twice and referred to the Committee on Finance.
The Biosimilars Access and Affordability Act would delay when generic versions of biologic drugs become eligible for Medicare price negotiations. Under current law, biosimilars can be selected for price negotiations nine months after FDA approval, but this bill extends that timeline to two years. The legislation includes an automatic delay if a manufacturer publicly announces that a biosimilar is in development or expected to reach the market within two years, and allows manufacturers to request additional delays if they can demonstrate a high likelihood their biosimilar will be approved and marketed. If a biosimilar fails to reach the market within the extended timeframe, the manufacturer must pay rebates to Medicare. The changes would take effect for price negotiations beginning in 2027 and are intended to give biosimilar manufacturers more time to develop and bring their products to market.
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