Biosimilar Red Tape Elimination Act
Sponsored By: Senator Lee, Mike [R-UT]
Introduced
Summary
Changes how biosimilars become ‘interchangeable’ by creating a new, two-part deemed‑interchangeability framework and reorganizing the approval rules in section 351(k) of the Public Health Service Act. The bill would set a 60‑day transition clock after enactment, preserve certain existing exclusivity periods, and force updates to FDA guidance on interchangeability and biosimilarity.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Faster biosimilar approval rules
If enacted, the HHS Secretary would have to update FDA guidance to reflect the bill within 18 months. The agency would revise or revoke prior interchangeability guidances and issue clear rules on what data applicants must submit. The Secretary would also be required to find that an application includes enough information to show biosimilarity. The bill would treat most 351(k) biosimilars as not a 'new active ingredient' for certain FDA rules, with narrow pediatric exceptions, and make related technical edits.
Faster biosimilar interchangeability rules
If enacted, many biosimilars licensed under the 351(k) pathway would be treated as interchangeable with the original drug. The transition date would be 60 days after enactment. Products licensed on or after that date would usually be interchangeable when licensed, unless they rely on the same reference product as another product that has a first interchangeable exclusivity period in effect; then they would wait until that exclusivity ends. Any unexpired first interchangeable exclusivity that was already running before enactment would continue for its remaining time.
Sponsors & CoSponsors
Sponsor
Lee, Mike [R-UT]
UT • R
Cosponsors
Sen. Luján, Ben Ray [D-NM]
NM • D
Sponsored 6/4/2025
Sen. Paul, Rand [R-KY]
KY • R
Sponsored 6/4/2025
Sen. Hassan, Margaret Wood [D-NH]
NH • D
Sponsored 6/4/2025
Sen. Schmitt, Eric [R-MO]
MO • R
Sponsored 6/24/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov