Biosimilars Access and Affordability Act

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In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Extends Medicare drug price negotiation delays for certain biological products to 2 years.

This bill would extend the time Medicare waits to negotiate prices for certain complex drugs, called biological products, from 1 year to 2 years. This delay would happen if a similar version (a biosimilar) is expected to enter the market soon. This change aims to allow more time for biosimilars to enter the market. For some drugs, this could mean Medicare price negotiations are delayed for an extra year.

What Would Change

Today, certain biological products can get a 1-year delay in Medicare price negotiations if a biosimilar is expected to enter the market. This bill would extend that potential delay to 2 years. It would also create an automatic delay process and modify the rebate rules for drug companies if a biosimilar doesn't become available within the extended 2-year period.

Key Provisions

Extends the delay for Medicare price negotiations for certain biological products from 1 year to 2 years if a biosimilar is expected to enter the market.
Establishes an automatic delay for Medicare price negotiations if a biosimilar manufacturer publicly announces its progress and the government expects the biosimilar to be sold within 2 years.
Requires drug companies to pay a rebate if a biosimilar does not become available during the 2-year delay period.
Modifies how rebates are calculated, setting them at 75 percent for Part D drugs and 80 percent for Part B drugs of the difference between the drug's price and its negotiated maximum fair price.
Clarifies that patent lawsuits would not prevent a finding that a biosimilar is highly likely to be marketed.

View on Congress.gov

HR 10628 · 119th Congress · AI Summary by gemini-2.5-flash · 7/10

Biosimilars Access and Affordability Act

What Would Change

Key Provisions

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