Bills · HR 5526
IN COMMITTEE· 119TH CONGRESS
House BillHR 5526Licensing and registrationsDrug safety, medical device, and laboratory regulation
Biosimilar Red Tape Elimination Act
INTRO SEP 19· LAST ACTION SEP 19
READING
7MIN
COSPONSORS
10BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because biologic drugs are often very expensive, and they treat a wide range of serious conditions from cancer to autoimmune diseases. Biosimilars offer a way to create competition and potentially lower these costs. The 'interchangeable' designation is key because it allows pharmacies to switch to a biosimilar without extra doctor approval, similar to how generic drugs are substituted. By making biosimilars automatically interchangeable upon their initial approval, this bill aims to speed up their market entry and adoption.
If this bill becomes law, consumers could see lower drug costs and improved access to these vital medications more quickly. If it doesn't pass, biosimilars would continue to face the additional, separate 'interchangeable' approval process, which can delay market competition and potentially keep drug prices higher for longer, affecting patients' access and affordability.
KEY PROVISIONS
4AI-extractedPROVISION 01
Removes the separate approval pathway for interchangeability; a biosimilar will automatically be deemed 'interchangeable' upon its initial FDA licensure.
This simplifies and potentially speeds up the process for biosimilars to become eligible for pharmacy-level substitution.
PROVISION 02
Applies automatic interchangeability to new biosimilars and, with some exceptions, to existing biosimilars 60 days after the bill's enactment.
This ensures the new policy has broad application to both future and many currently approved biosimilars.
PROVISION 03
Preserves existing 'first interchangeable exclusivity' periods for biosimilars that were in effect before the bill's enactment.
This protects the market rights of biosimilar manufacturers who secured exclusivity under previous regulations.
PROVISION 04
Requires the Secretary (FDA) to update existing guidance documents within 18 months to reflect the new automatic interchangeability rules.
This ensures clear instructions and expectations for manufacturers and other stakeholders regarding the updated regulations.
SPONSORSHIP
1 + 10
R· Texas
YRS IN OFFICE
5
BILLS LED
62
COSPONSOR BREAKDOWNBIPARTISAN · 80%
DEM 4 REP 6 IND 0
ACTION TIMELINE
2 EVENTSSEP 19
Introduced in House
SEP 19
Referred to the House Committee on Energy and Commerce.
BILL INFO
TypeHouse Bill
NumberHR 5526
Congress119th
StatusIn Committee
IntroducedSep 19, 2025
Last actionSep 19, 2025
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IN COMMITTEE· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED SEP 19, 2025
House BillHR 5526Licensing and registrationsDrug safety, medical device, and laboratory regulation
Biosimilar Red Tape Elimination Act
INTRODUCED SEP 19, 2025· LAST ACTION SEP 19, 2025
PASSAGE CHANCES
—%
READING
7 min
COSPONSORS
10
COMPLEXITY
Moderate
