Biosimilars Access and Affordability Act
Sponsored By: Representative Langworthy, Nicholas A. [R-NY-23]
Introduced
Summary
Creates a two-year delay framework for biosimilars in Medicare drug-price negotiations. The bill would tie when a biological product becomes a "selected drug" to the negotiation list's publication date and add new evidentiary and verification steps for delaying price limits.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Rebates if biosimilars fail to launch
If enacted, manufacturers that get a two-year delay but then do not have an FDA-licensed and marketed biosimilar would have to pay rebates for the years they delayed pricing. Rebates would be calculated each quarter as 75% of how much the average manufacturer price (AMP) exceeded the benchmark and 80% of how much the Medicare Part B payment amount exceeded the benchmark. Benchmarks would be the negotiated maximum fair price in the first year and the increased maximum fair price in the second year. This rule would start for price years beginning in 2027.
Two-year biosimilar delay rules
This bill would let the Secretary delay listing a biologic as a negotiated drug for two years when a biosimilar is near launch. The Secretary could delay automatically if FDA filings or required studies show a biosimilar is likely to market within two years. A manufacturer could also ask for delay and must give evidence and a written attestation, including an expected launch date and capital plans, under penalty of perjury. The rule would start for price years that begin in 2027, and pending or prospective patent lawsuits would not by themselves block a delay.
Delay publishing negotiated drug prices
This bill would let the government delay publishing a negotiated maximum fair price and its explanation for an initial year if negotiations are still ongoing. If publication is deferred, that negotiated price would not apply for that initial year. The bill would also tie when a drug counts as a "selected drug" to the year of the publication date, which changes the sequencing of which drugs face negotiation and when. These timing changes would take effect for price years beginning in 2027.
Sponsors & CoSponsors
Sponsor
Langworthy, Nicholas A. [R-NY-23]
NY • R
Cosponsors
Rep. Auchincloss, Jake [D-MA-4]
MA • D
Sponsored 9/28/2026
Rep. Joyce, John [R-PA-13]
PA • R
Sponsored 9/28/2026
Rep. Sánchez, Linda T. [D-CA-38]
CA • D
Sponsored 9/28/2026
Rep. Peters, Scott H. [D-CA-50]
CA • D
Sponsored 9/28/2026
Rep. Yakym, Rudy [R-IN-2]
IN • R
Sponsored 9/28/2026
Rep. Moran, Nathaniel [R-TX-1]
TX • R
Sponsored 9/28/2026
Rep. Mullin, Kevin [D-CA-15]
CA • D
Sponsored 9/28/2026
Rep. Panetta, Jimmy [D-CA-19]
CA • D
Sponsored 9/28/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov