Lawmakers Introduced Medicare Biosimilar Negotiation Bill
The legislation establishes a defined two-year delay period for Medicare price negotiations on certain drug products.
Updated on Oct. 2, 2026 in Legislative Policy
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Representative Nick Langworthy and Senator Marsha Blackburn have introduced the Biosimilars Access and Affordability Act in Congress. The bill creates a structured path for a two-year Medicare negotiation delay for biosimilar manufacturers.
Why it matters
This legislation aims to prevent premature price negotiations for competitors while ensuring that original biologics face market pressure if a biosimilar fails to launch within the specified two-year window.
The proposed measure mandates that manufacturers pay rebates if a biosimilar is not marketed within the two-year delay period. It currently lacks a formal Congressional Budget Office cost estimate.
The players
Nick Langworthy
Representative Nick Langworthy is a U.S. Congressman who sponsored the Biosimilars Access and Affordability Act in the House of Representatives.
Marsha Blackburn
Senator Marsha Blackburn is a U.S. Senator who introduced the companion version of the legislation in the Senate.
Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center is a Buffalo-based research institution that has publicly supported the proposed legislation.
The details
The bill allows manufacturers to qualify for the negotiation delay by utilizing FDA-accepted applications or evidence from clinical studies. It also provides a pathway for companies to qualify if they can demonstrate that a biosimilar will likely reach the market despite ongoing patent litigation.
Timeline
Representative Nick Langworthy introduced the bill on September 25, 2026.
Political Context
The proposed measure seeks to modify the negotiation timeline established by the Inflation Reduction Act's Medicare drug-price negotiation provisions. Critics and industry observers often push back on such delays, arguing that they may extend the period during which high-cost drugs remain exempt from price pressure.
If enacted, this policy could impact federal health expenditures and the speed at which lower-cost biosimilar drugs reach patients under Medicare. Taxpayers and Medicare beneficiaries will be affected by the ultimate budgetary impact of the law, which currently remains uncalculated.
The takeaway
The bill represents a significant effort to standardize how federal regulators treat the entry of biosimilars into the competitive pharmaceutical market. Stakeholders should monitor for future Congressional Budget Office reports that will clarify the potential financial impact of these rules.
Further reading
For more background on federal drug pricing reforms, visit the Legislative Policy section.
Source note: This article includes information reported by Fingerlakes1.
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Should Medicare delay price negotiations for biologics to help biosimilar drugs reach the market?
