Biosimilars Access and Affordability Act

Summary#

The Biosimilars Access and Affordability Act would amend the Social Security Act’s Medicare drug-price negotiation rules. Its stated goal is to change when biosimilar biological products can delay a reference biologic’s eligibility for price negotiation; the bill does not guarantee that a biosimilar will reach the market.

  • The Secretary would have to apply a delay of up to two years if specified information shows that a biosimilar is in development and its manufacturer expects it to be marketed within the stated period.
  • The Secretary could also grant a delay on request if there is clear and convincing evidence that the biosimilar will be marketed within the required period.
  • For both routes, the Secretary must share the information being relied on with the biosimilar manufacturer and require it to confirm or correct the information in writing, under penalty of perjury. Pending or expected patent litigation would not, by itself, prevent a delay.
  • If the biosimilar is not licensed and marketed by the deadline, the reference biologic’s manufacturer must pay a rebate for certain years when a maximum fair price would otherwise have applied. The bill also changes when selected-drug status and maximum-fair-price publication or application occur in these cases.
  • The bill removes an exclusion for “extended monopoly” drugs from the biosimilar-related delay provisions.

What it means for you#

  • Medicare beneficiaries: The bill does not directly change who qualifies for Medicare or create a new benefit. In cases where a delay applies, a negotiated maximum fair price may not apply for the initial price-applicability year.
  • Reference-biologic manufacturers: A qualifying delay could postpone the price-negotiation schedule. If no biosimilar is licensed and marketed by the deadline, the manufacturer must pay the required rebate.
  • Biosimilar manufacturers: The Secretary may rely on information about the product’s development and expected marketing date. The manufacturer must confirm or correct relevant information under penalty of perjury. The bill does not set a launch requirement for the biosimilar manufacturer.
  • The Secretary: Must apply the automatic delay when its conditions are met and make the required determinations. The bill does not specify an application process, decision timeline, or appeal process.
  • The public: The bill is not law. It was introduced in the Senate and referred to the Finance Committee. It says its changes apply to initial price-applicability years beginning with 2026.

Money#

No publicly available information gives a federal cost estimate.

  • If a biosimilar is not licensed and marketed by the deadline, the reference-biologic manufacturer must pay a rebate. For Part D, the formula uses 75% of the amount by which the product’s average manufacturer price exceeds the relevant maximum fair price. For Part B, it uses 80% of the amount by which the payment amount exceeds that price. The second-year comparison uses an inflation-adjusted maximum fair price.
  • The bill gives no estimate of rebate totals, Medicare savings, or the cost of administering the changes.

What is unclear#

  • The Social Security Act provisions being amended were not supplied, so the current rules and the full effect of the amendments against current law could not be verified.
  • The bill does not explain how the Secretary would assess an expected marketing date, or what evidence would be enough for the automatic delay.
  • The bill does not set timelines, appeal rights, or other details for the Secretary’s decisions.
  • The bill applies beginning with 2026 price-applicability years but does not explain how that date would work if the bill became law later.
  • The bill defines “marketed” as introduced or delivered for introduction into interstate commerce, but does not explain how that definition would apply in disputed cases.

Case for#

  • A possible argument for the bill is that a reference biologic’s negotiation schedule should account for a biosimilar that is close to market.
  • The two-year delay could give time for the biosimilar to be licensed and marketed before the reference biologic’s negotiated price applies.
  • The rebate requirement could reduce the advantage of a delay if the biosimilar does not reach the market by the deadline.
  • Allowing a delay despite patent litigation could avoid treating litigation alone as proof that a biosimilar will not launch.

Case against#

  • A delay could postpone a negotiated Medicare price even if the biosimilar ultimately does not reach the market; the rebate would be paid later.
  • The Secretary’s decision would partly depend on expectations about a future launch, and the bill leaves important parts of that assessment process unspecified.
  • The written confirmation under penalty of perjury and rebate calculations could add administrative work for manufacturers and the federal government; the bill gives no cost estimate.
  • It is unclear how the revised rules would interact with the existing Medicare negotiation process, because the current law was not provided.