Biosimilars Access and Affordability Act

S 5459, the Biosimilars Access and Affordability Act, extends the timeline for biosimilar drugs to enter Medicare Part D negotiations. It changes the current 1-year delay period to a 2-year period, allowing biosimilar manufacturers to request an automatic delay if they disclose FDA application acceptance, ongoing clinical studies, or a planned market launch date. If a biosimilar isn't marketed within the extended timeframe, the manufacturer must pay rebates for years they would have provided access to negotiated prices. This directly affects biosimilar drug manufacturers and Medicare Part D program pricing for biological products. The changes apply to initial price negotiations starting in 2027.