Congress Introduced Bills to Reform Biosimilar Pricing
New legislation aims to provide clarity on Medicare price negotiations to encourage biosimilar market entry.
Updated on Oct. 1, 2026 in Healthcare
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Members of Congress have introduced H.R.10628 and S.5571 to address uncertainty surrounding biosimilar eligibility for Medicare price negotiations. The bills aim to streamline market access for lower-cost alternatives to expensive biologic drugs.
Why it matters
Current policies create unpredictability for manufacturers, hindering investments in biosimilar development. Providing legislative clarity is intended to accelerate market entry and address the 30 percent of Americans who report skipping prescriptions due to high costs.
Developing a biosimilar costs up to $300 million and takes nine years, while these drugs average more than 50 percent lower-cost than reference biologics. Savings are projected to reach $181 billion over the next five years.
The players
House of Representatives
The chamber where H.R.10628 was introduced with eight bipartisan co-sponsors.
Senate
The chamber where S.5571 was introduced by a group of four senators.
The details
The proposed legislation seeks to codify clear rules for when biosimilar products qualify for Medicare price negotiations. With 118 biologics set to lose patent protection in the next decade, proponents argue these changes are vital to foster competition and reduce consumer financial burdens.
Timeline
118 biologics are expected to lose patent protection over the next decade.
Biosimilar savings are projected to reach $181 billion over the next five years.
Market Landscape
This legislation modifies the regulatory framework created by the Inflation Reduction Act's Medicare drug-price negotiation provisions. By addressing eligibility gaps, the bills aim to shift market dynamics to favor biosimilar competition over entrenched biologic monopolies.
The legislation could help lower out-of-pocket medication costs for patients who currently struggle to afford prescriptions. By streamlining the entry of lower-cost biosimilars, it may also reduce long-term price inflation for biologic treatments.
The takeaway
Legislative clarity is essential for manufacturers to commit the $300 million required for biosimilar development. Encouraging these lower-cost alternatives is a key strategy for addressing the affordability crisis in American healthcare.
Further reading
Learn more about the latest policy developments in Healthcare.
More information
Review the latest industry data and advocacy updates at the Biosimilars Forum information and resources.
Source note: This article includes information reported by Firstwordpharma.
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Should government policy prioritize lower drug prices through Medicare negotiations even if it risks innovation competition?
