Biosimilars Access and Affordability Act
Allows Medicare price negotiations for certain biological drugs to be delayed while a biosimilar is expected to reach the market.
In the Senate Finance Committee since Sept. 28, 2026, 10 days after it was introduced. Most bills never leave committee.
- INTRODUCEDINTROSEP 28, 2026
- COMMITTEECOMM.IN COMMITTEE
- SENATESENATE—
- HOUSEHOUSE—
- LAWLAW—
What the bill would do, and why it matters
Medicare negotiates prices for selected drugs, including biological medicines. The bill would allow certain negotiations to be delayed for up to two years when a biosimilar is expected to reach the market. If it does not, the maker of the reference drug would owe rebates for the delayed years.
- 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.
- Extends biosimilar-related delays to two years
For certain biological drugs, the bill would allow Medicare price negotiations to be delayed for two years while a biosimilar is expected to reach the market.
- Starts automatic delays based on biosimilar progress
An automatic delay would apply when there is information that a biosimilar application was accepted for FDA review or approved, or that relevant clinical studies are underway, complete, or unnecessary. The Secretary would also have to determine that the biosimilar maker expects to market the product within two years after the selected drug publication date.
- Sets evidence rules for requested delays
For a delay requested under the existing process, the Secretary would have to find clear and convincing evidence that the biosimilar will be marketed within the specified period. Pending or prospective patent litigation would not, by itself, rule out a delay.
- Requires rebates if a biosimilar does not launch
If a biosimilar is not licensed and marketed by the specified two-year point, the reference-product maker would owe rebates for the delayed years. The bill sets the rebate at 75% of the relevant price difference for Part D and 80% for Part B, with a specified adjustment for the second year.
- Applies changes beginning with 2026 price years
The changes would apply to initial price applicability years beginning with 2026.
The timing of Medicare price negotiations can affect when a negotiated price applies to a biological drug. The bill would give a potentially competing biosimilar more time to reach the market before that price takes effect, while requiring rebates if the expected competition does not arrive within the specified period.
Written from the bill text.
The path it took, step by step
- IntroducedSEP 28, 2026SENATESEP 28, 2026By Sen. Blackburn with 3 original cosponsorsReferred to Finance
- SAME DAYNOWSenate committeeSEP 28, 2026FINANCE NOWSEP 28, 2026In committee for 10 daysNo hearing yet
- 10 DAYS SO FARPassed the Senate—SENATE FLOOR—Not scheduled
- House committee—HOUSE—
- Passed the House—HOUSE 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, 2026REFERREDRead twice and referred to the Committee on Finance.
- SEP 282026SEP 28, 2026INTRODUCEDSENATEIntroduced in Senate
At day 10, 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 3 states
Plus the sponsor, a Republican. The smaller side has 1 member.
Plus the sponsor, a Republican. The smaller side has 1 member.
Sen. Blackburn’s record: sponsored 145 bills this Congress. 13 passed the Senate; 1 became law.
- Ted BuddR-NCORIGINAL
- James LankfordR-OKORIGINAL
- Adam B. SchiffD-CAORIGINAL
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