H.R. 10628

Highlight any text to annotate

# Summary The Biosimilars Access and Affordability Act modifies Medicare's drug price negotiation program to delay when biosimilar drugs become eligible for price negotiations. Under current law, biologic drugs become subject to Medicare price negotiations nine months after a biosimilar version is approved. This bill extends that timeline to two years, meaning if a manufacturer demonstrates that a biosimilar is in development or under FDA review, the original biologic drug can avoid price negotiations for an additional year. The bill applies automatic delays based on publicly available information about biosimilar development and allows manufacturers to request additional delays if they can demonstrate with "clear and convincing evidence" that a biosimilar will reach the market within two years. If no biosimilar actually reaches the market within the two-year window, manufacturers must pay rebates to Medicare for the delayed negotiation period. The changes take effect for Medicare's 2027 price negotiation year.

Add a comment

Sign in 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.