H.R. 10628
Biosimilars Access and Affordability Act
Summary:
• The "Biosimilars Access and Affordability Act" amends title XI of the Social Security Act to change when biosimilar biological products become eligible for Medicare drug price negotiations.
• The bill extends the delay period for including a biological product as a "selected drug" subject to price negotiation from 1 year to 2 years when a biosimilar competitor product is expected to enter the market.
• The bill establishes an automatic delay mechanism (in addition to an existing request-based delay) when a biosimilar's application has been accepted or approved by the FDA, or relevant clinical studies are underway or complete, and the biosimilar is expected to be marketed within 2 years of the selected drug publication date.
---
• The bill extends the delay period for including a biological product as a "selected drug" subject to price negotiation from 1 year to 2 years when a biosimilar competitor product is expected to enter the market.
• The bill establishes an automatic delay mechanism (in addition to an existing request-based delay) when a biosimilar's application has been accepted or approved by the FDA, or relevant clinical studies are underway or complete, and the biosimilar is expected to be marketed within 2 years of the selected drug publication date.
---