Congress·In Committee·H.R. 5526

House Committee Reviews Bill to Grant Biosimilars Automatic Interchangeable Status at Approval

Biosimilar Red Tape Elimination Act

6 months ago·View on Congress.gov

Part of: Legislative Push to Automate Biosimilar Substitution and Lower Drug Costs

⏸

Stalled

No legislative action in over 90 days.

Legislative Progress

House

Senate

President

Law

Key Points

Would make most biosimilar medicines automatically interchangeable with the original biologic once approved, instead of needing a separate extra decision.
Sets a switch-over date 60 days after the bill becomes law. Biosimilars approved before then become interchangeable on that date.
Keeps existing “first interchangeable” exclusivity protections for certain older products, so some automatic switching could be delayed until that period ends.
Requires the Health Department to update and revise its public guidance within 18 months so drug companies know what data to submit.
Does not change the basic safety and effectiveness standard for biosimilars; it mainly changes how interchangeability is handled and documented.

HealthcarePrescription DrugsConsumer Protection

Impact Analysis

Personal Impact

How this policy affects specific groups of people

Mixed Impacts(3)

Medicare

Neutral

Medicaid

Neutral

Retiree

Neutral

Positive Impacts(2)

Chronic Illness

Helps

Disability Benefits

Helps

Milestones

2 milestones2 actions

Sep 19, 2025House

Referred to the House Committee on Energy and Commerce.

Sep 19, 2025

Introduced in House

What Happens Next

Projected impacts based on AI analysis

60 days after enactment

60 days after the bill is enacted, FDA-treated “interchangeability” changes kick in for biosimilars.

Newly approved biosimilars would generally be considered interchangeable right away, and older approved biosimilars would generally become interchangeable on that date—except where a protected exclusivity period delays it.

Depends on each product’s remaining exclusivity period

Existing protected “first interchangeable exclusivity” periods continue until they naturally end.

For a few reference products where an older product already has this protected window, a newer biosimilar may have to wait to be treated as interchangeable, even after the transition date.

Related News

2 articles

Fierce Pharma·9 months ago

Advocacy groups, health networks and others back bill seeking to nix 'interchangeable' biosim tag

More than 39 advocacy groups are championing the bipartisan Biosimilar Red Tape Elimination Act, which aims to remove the distinction between biosimilars and interchangeable biosimilars. While supporters cite increased competition, PhRMA argues the bill could weaken safety standards.

AJMC·over 2 years ago

Senator reintroduces Biosimilar Red Tape Elimination Act

Senator Mike Lee reintroduced legislation to deem all biosimilars as interchangeable upon FDA approval. The bill aims to eliminate the 'switching study' requirement, which the bill's sponsors argue is a bureaucratic hurdle that protects brand-name monopolies and keeps drug prices high.

C+