FDA biosimilar interchangeability rule eliminated under HR 5526
In committeeH.R. 5526Latest action
Sponsor: August Pfluger · Representative · TX
AIDecoded by AI · checked against the recordRead the official text
Official title: Biosimilar Red Tape Elimination Act
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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HR 5526 removes the FDA's extra interchangeability approval step, letting pharmacists auto-substitute biosimilars once they are approved as safe and similar.
50-second read · 4 questions answered below
What does this do?
HR 5526 eliminates the separate FDA approval step that biosimilars must currently pass to be labeled interchangeable with a brand-name biological drug. Once a biosimilar is approved as safe and sufficiently similar to the original, it is automatically considered interchangeable. The change takes effect 60 days after enactment and applies to biosimilars already on the market at that time.
Who does it affect?
Patients who take biological drugs are most directly affected, as pharmacists would be able to substitute lower-cost biosimilars without a new prescription. Brand-name biological drug manufacturers and biosimilar makers are also affected, and the FDA must update its guidance documents within 18 months.
Why does it matter?
Removing the extra approval step could increase the number of biosimilars eligible for pharmacy-level substitution, which may introduce more competition in the market for biological drugs. Existing exclusivity protections earned by biosimilar companies for being first to achieve interchangeable status remain in force until they expire.
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Where does it stand?
- IntroducedSep 19, 2025
- House committeeYou are here · Sep 19, 2025
- House vote
- Senate
- The president's desk
Right now: a House committee is reviewing it. If the Senate changes it, it goes back to the House before reaching the president.
Latest action: — Referred to the House Committee on Energy and Commerce.