Nonpartisan civic infrastructure
AllCiv·Legis1
·

S. 5571

BillFederalSenateIn Committee
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 · September 28, 2026
Read twice and referred to the Committee on Finance.
Introduced
September 28, 2026
Cosponsors (3)
1D 2R
View PDF ↗

Summary

Highlight any text to annotate
# Biosimilars Access and Affordability Act Summary This bill changes the Medicare drug price negotiation rules to delay when biosimilar drugs (cheaper alternatives to expensive biologic drugs) become subject to price negotiations. Currently, biosimilars can enter Medicare's negotiation program relatively quickly after they are approved. This bill would automatically delay a biologic drug's inclusion in price negotiations for up to two years if a biosimilar competitor is in development or approval, giving manufacturers more time before prices are negotiated. The delay can be triggered automatically when biosimilar manufacturers disclose they are pursuing FDA approval or when the government determines a biosimilar will likely reach the market within two years. However, if no biosimilar actually launches within that two-year window, the original drug must then enter price negotiations and the manufacturer may owe rebates for the delayed years. The bill also allows manufacturers to request additional delays if they provide certain documentation about biosimilar development timelines. These changes take effect for Medicare price negotiations beginning in 2026.

Take Action

Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.