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S5571119th CongressWALLET

Biosimilars Access and Affordability Act

Sponsored By: Senator Blackburn, Marsha [R-TN]

Introduced

Summary

Two-pathway, two-year delay that changes when biosimilars enter Medicare price negotiations. It also adds disclosure duties, a "high likelihood" test, and new rebate and price-adjustment rules.

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  • Manufacturers must disclose licensure status, study progress, and expected launch dates and confirm those facts in writing under penalty of perjury. False confirmations trigger enforcement and manufacturers can owe rebates if they do not license and market within the delay.
  • The bill ties a drug's negotiation start to its selected drug publication date and creates automatic and request-based delays that can push inclusion by up to two years. The maximum fair price does not apply during the initial price applicability year and the changes apply to initial price applicability years beginning 2026.
  • When delays apply, the law imposes price-adjustment formulas for each missed quarter that reclaim part of excess costs: 75 percent of average manufacturer price excess and 80 percent of the payment amount excess. It also creates a formal "high likelihood" standard for delay-on-request decisions and says pending patent litigation will not block a delay.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 0 costs, 2 mixed.

Manufacturer rebates for biosimilar delays

This bill would require drug makers to pay quarterly rebates if a biosimilar is not licensed and marketed within two years after the selected-drug publication date. For Part D the rebate would be 75% of the amount the product's average manufacturer price (AMP) exceeds the applicable maximum fair price for each quarter. For Part B the rebate would be 80% of the amount Medicare paid above that same benchmark each quarter. The second year of a delay would use an increased maximum fair price benchmark. These rebates would start for initial price applicability years beginning in 2026.

Delay Medicare biosimilar price talks

This bill would let the Secretary delay treating some biological products as selected drugs for Medicare negotiation for up to two years when a biosimilar is expected within that window. There would be an automatic two-year pathway and a delay-on-request pathway that requires a high-likelihood finding based on clear and convincing evidence. Manufacturers must disclose and confirm information the Secretary relies on under penalty of perjury, and patent litigation alone would not block a delay. If negotiations are unfinished and a maximum fair price is not published, no negotiated price would apply for that initial price applicability year. These rules would begin for price years starting in 2026.

Sponsors & CoSponsors

Sponsor

Blackburn, Marsha [R-TN]

TN • R

Cosponsors

  • Sen. Schiff, Adam B. [D-CA]

    CA • D

    Sponsored 9/28/2026

  • Sen. Lankford, James [R-OK]

    OK • R

    Sponsored 9/28/2026

  • Sen. Budd, Ted [R-NC]

    NC • R

    Sponsored 9/28/2026

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
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