Bill · H.R. 10628· House(119-HR-10628)
Biosimilars Access and Affordability Act
- Introduced
- 9/28/2026
- Last activity
- 9/28/2026 — 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.
- Sponsored by
- Nicholas Langworthy
- Cosponsors
- - 3 - 5
- Introduced
- In Committee
What this bill would do
The bill, known as the Biosimilars Access and Affordability Act, changes when certain biological products are eligible for price negotiations under Medicare. It amends title XI of the Social Security Act to alter the timeline for these negotiations. Specifically, the bill adjusts the rules regarding when biosimilar biological products can delay reference product price negotiations. It also establishes requirements for automatic delays and outlines penalties or rebates if a biosimilar is not successfully marketed during the delay period. These changes apply to initial price applicability years beginning with the year 2027.
Yes
Would business owners be better off under this?+3
Biological product manufacturers and brand-name drug companies may benefit from extended delay periods before price negotiations take effect.
Does this put more money into Medicare, the health coverage for people over 65?+2
The bill amends Medicare price negotiation timelines for biological products, creating financial mechanisms that impact program expenditures.
The opposite· 3 of 4
Does this lower the price of prescription medicines?-4
Extending the delay period for Medicare price negotiations on certain biological products could keep prescription drug costs higher for a longer period.
Would people over 65 be better off under this?-3
Delaying Medicare price negotiations for certain biological products may keep drug prices higher for seniors who rely on Medicare.
Would retired people be better off under this?-3
Retirees depending on Medicare may face higher out-of-pocket costs due to delayed price negotiations.
Who it would affect, and how
Potential Positive Impacts for People
- Encouraging Competition: Under Section 2, the bill provides an automatic delay for price negotiations if a manufacturer expects to market a biosimilar biological product within two years. This provision encourages the development and introduction of lower-cost biosimilar options for patients.
Potential Negative Impacts for People
-
Delayed Price Reductions: Section 2 extends certain delay periods from one year to two years. This means Medicare price negotiations and subsequent maximum fair prices for certain reference biological products could be delayed, potentially keeping drug costs higher for a longer period.
-
Financial Penalties and Rebates: Section 2 establishes that if a delayed biological product is not actually licensed and marketed within the two-year period, the manufacturer must pay a specific rebate. This adds complex financial accountability measures that could impact the healthcare market.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners+3Good For Retirees-3Good For Seniors-3Good For Low Income Households-2
- Healthcare
- Increases Medicare Funding+2Reduces Prescription Drug Costs-4
- 9/28/2026
- 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.
- 8 Cosponsors added.
- Introduced in House
Jake AuchinclossDemocrat · Massachusetts
John JoyceRepublican · Pennsylvania
Nathaniel MoranRepublican · Texas
Kevin MullinDemocrat · California
Scott PetersDemocrat · California
Jimmy PanettaDemocrat · California
Linda SánchezDemocrat · California
Rudy YakymRepublican · Indiana