S. 5571 — Biosimilars Access and Affordability Act

This section extends the exclusion of biological products from Medicare drug price negotiation due to biosimilar competition to 2 years (from 1 year) after the selected drug publication date. It establishes an automatic delay process when a biosimilar manufacturer discloses an accepted FDA application, ongoing or completed clinical studies, or expected marketing within that 2-year window, and requires the Secretary to confirm such information before applying the delay.