Bill delays Medicare drug price negotiations for expensive biologics by 15 months

What it does

This bill delays when biologic drugs become eligible for Medicare price negotiations if a cheaper biosimilar (generic-like alternative) is expected to enter the market soon. Instead of a drug entering price negotiations 9 months after FDA approval, it now stays out of negotiations for up to 2 years if a biosimilar manufacturer confirms it expects to launch within that window. If the biosimilar doesn't actually launch, the original drug enters negotiations and the biosimilar maker owes a rebate.

Why we flagged it

The bill's operative mechanism is a straightforward extension of the timeline before reference biologics enter Medicare price negotiations. It is not disguised, but the title 'Biosimilars Access and Affordability Act' actively misdirects: the bill does not improve biosimilar access or affordability—it delays price negotiations on the reference drug, which may actually slow biosimilar uptake by allowing reference biologics to remain expensive longer.

What the text implies

• The bill's framing as 'biosimilar access' obscures that delaying reference drug price negotiations may reduce the price advantage of biosimilars, potentially slowing their market adoption and reducing actual biosimilar competition.
• The 2-year delay applies even if the biosimilar manufacturer's timeline is speculative; the bill requires only a written confirmation 'under penalty of perjury' of expected marketing date, creating a low evidentiary bar for manufacturers to trigger the delay.
• If a biosimilar does not launch within 2 years, the reference drug enters negotiations and the biosimilar maker pays a rebate—but by then the reference manufacturer has enjoyed 2 years of uncontrolled pricing, and the rebate may not fully offset the program's losses.
• The bill's 'high likelihood' standard for biosimilar launch relies on Secretary determination from 'any source,' creating discretion and potential for manufacturer influence over what counts as credible evidence of imminent launch.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

Medicare beneficiaries and the federal program will pay higher prices for biologic drugs for an additional 15 months (from 9 months to 2 years) while waiting for biosimilar competition. The bill prioritizes reference biologic manufacturers' pricing power over near-term cost control, shifting the cost burden to patients and taxpayers.

Who stands to gain

• reference biologic manufacturers (Amgen, Regeneron, Eli Lilly, Janssen, AbbVie, etc.)
• large pharmaceutical companies with biologic portfolios

Named in the bill

Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), Social Security Act Section 1192, Public Health Service Act Section 351(k), Medicare Part D, reference biologic manufacturers, biosimilar manufacturers

Where it stands

8 cosponsors: 5 Democrats, 3 Republicans.

• Sep 28, 2026 — Introduced · Congress.gov: “Introduced in House”
• Sep 28, 2026 — Referred to House Committee on Ways and Means and House Committee on Energy and Commerce · Congress.gov: “Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a…”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.