Proposed
Bill · 119th Congress · HR 10628
Biosimilars Access and Affordability Act
Refreshed 1 h ago
Introduced 2026-09-28Topic: health careSummary
AI-generated summary, report an errorThis bill changes the rules for when a brand-name biological drug can be picked for Medicare price negotiation if a lower-cost copy (a biosimilar) is expected to come to market. It extends the possible delay of negotiation from 1 year to 2 years, and makes the delay automatic in some cases when the biosimilar maker has reached certain approval or testing steps and expects to market the product within 2 years. Biosimilar makers must confirm the information in writing under penalty of perjury, and pending patent lawsuits do not block a delay. If the biosimilar is not licensed and marketed in time, the brand-name drug is added to the negotiation list and its maker must pay Medicare a rebate for the delayed years. The changes apply starting with price year 2027.
Sponsors
- Nicholas A. Langworthy Republican sponsor
- 9 cosponsors
Action history
| Date | Chamber | Action | Status effect |
|---|---|---|---|
| 2026-09-28 | House | Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. | refer |
| 2026-09-28 | House | Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. | refer |
| 2026-09-28 | Introduced in House | introduce | |
| 2026-09-28 | Introduced in House | introduce |