Biosimilars Access and Affordability Act
Extends Medicare negotiation delays when a biosimilar is expected to reach the market and requires rebates if it does not.
In two House committees since Sept. 28, 2026, 7 days after it was introduced. Most bills never leave committee.
- INTRODUCEDINTROSEP 28, 2026
- COMMITTEECOMM.IN COMMITTEE
- HOUSEHOUSE—
- SENATESENATE—
- LAWLAW—
What the bill would do, and why it matters
Medicare negotiates prices for certain prescription drugs, including biologic medicines. This bill would give some reference biologic drugs up to two years more before Medicare negotiation when a biosimilar is expected to enter the market. If the biosimilar does not reach the market within the specified period, the reference drug's manufacturer would owe rebates.
- INTRODUCED ONLY This bill has been introduced and possibly referred to a committee, but it has not passed any vote. Most introduced bills never become law — they die in committee without a hearing.
- DATA NOTE No Congressional Research Service summary was available.
- Extend delays for biosimilar entry
The bill would allow a delay of up to two years in Medicare price negotiation when a biosimilar is expected to reach the market. A delay could be granted on request based on clear and convincing evidence, or automatically when specified development steps have occurred and the manufacturer expects to market the biosimilar within the two-year period.
- Require manufacturers to confirm information
Before relying on information to grant a delay, the Secretary of Health and Human Services would have to share that information with the biosimilar manufacturer and require it to confirm or correct the information in writing under penalty of perjury. Pending or prospective patent litigation would not by itself prevent a delay.
- Require rebates if a biosimilar does not launch
If a biosimilar is not licensed and marketed by the specified two-year point, the reference product would be added to the Medicare negotiation list for a later year, and its manufacturer would owe rebates for the delayed period. The rebate calculation would use 75 percent of the specified price difference for Part D and 80 percent for Part B.
- Apply changes beginning in 2027
The changes would apply to initial price applicability years beginning with 2027.
The bill would change how the timing of Medicare price negotiation is tied to the expected arrival of a competing biosimilar. The practical stakes are when Medicare's negotiated price applies and whether the reference drug manufacturer owes rebates if the expected competition does not reach the market in time.
Written from the bill text.
The path it took, step by step
- IntroducedSEP 28, 2026HOUSESEP 28, 2026By Rep. Langworthy with 8 original cosponsorsReferred to Energy and Commerce and Ways and Means
- SAME DAYNOWHouse committeesSEP 28, 2026ENERGY & COMMERCE · WAYS & MEANS NOWSEP 28, 2026In committee for 7 daysNo hearing yet
- 7 DAYS SO FARPassed the House—HOUSE FLOOR—Not scheduled
- Senate committee—SENATE—
- Passed the Senate—SENATE FLOOR—Not scheduled
- Resolve differencesONLY IF NEEDEDBOTH CHAMBERSONLY IF NEEDEDSkipped if the other chamber passes the same text
- Signed into law—PRESIDENT—10 days to sign or veto
- SEP 282026SEP 28, 2026REFERREDReferred 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.
- SEP 282026SEP 28, 2026INTRODUCEDHOUSEIntroduced in House
At day 7, this bill is already older than 3% of the laws passed this Congress were when they were signed.
Where your members stand on it
A coalition from 5 states
Plus the sponsor, a Republican. The smaller side has 3 members.
Plus the sponsor, a Republican. The smaller side has 3 members.
Rep. Langworthy’s record: sponsored 50 bills this Congress. 9 passed the House; 0 became law.
- Jake AuchinclossD-MA-4ORIGINAL
- John JoyceR-PA-13ORIGINAL
- Nathaniel MoranR-TX-1ORIGINAL
- Kevin MullinD-CA-15ORIGINAL
- Jimmy PanettaD-CA-19ORIGINAL
- Scott H. PetersD-CA-50ORIGINAL
- Linda T. SánchezD-CA-38ORIGINAL
- Rudy Yakym IIIR-IN-2ORIGINAL
What readers think
Discussion
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