Expedited Access to Biosimilars Act

Sponsor: Nicholas A. Langworthy (Republican-NY)July 14, 2026

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Introduced

In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

Referred to the House Committee on Energy and Commerce.

Simplifies approval for cheaper versions of complex medicines.

This bill would make it easier and faster for new, cheaper versions of complex medicines, called biosimilars, to get approved. It would change how the Food and Drug Administration (FDA) reviews these drugs, requiring them to justify and give quick notice if certain studies are needed. This could mean more affordable treatment options for patients sooner.

What Would Change

Today, the FDA can require certain clinical studies for biosimilar drug approval without clear limits or deadlines for telling drug companies. After this bill, the FDA would not automatically expect these studies and would need to justify and provide written notice within 60 days if they are required. The bill would also remove a specific rule about how the FDA conducts its reviews.

Key Provisions

Limits when the FDA can require certain clinical studies, like those checking how a drug works or its effectiveness, for biosimilar drug approval.
Requires the FDA to give drug companies written notice within 60 days if these extra studies are needed.
Changes the specific rules for how drug companies assess how biosimilar drugs move through the body and affect the immune system.
Ends a specific requirement for how the FDA conducts its reviews of biosimilar drugs.

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HR 9661 · 119th Congress · July 14, 2026 · AI Summary by gemini-2.5-flash · 8/10

Expedited Access to Biosimilars Act

What Would Change

Key Provisions

Lobbying Activity