Biosimilar Red Tape Elimination Act
House Committee Reviews Bill to Grant Biosimilars Automatic Interchangeable Status at Approval
Stalled
No legislative action in over 90 days.
Legislative Progress
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.
Impact Analysis
Personal Impact
How this policy affects specific groups of people
Milestones
Referred to the House Committee on Energy and Commerce.
Introduced in House
The bill was officially filed and given a number. It now enters the legislative queue.
Votes
No votes have been recorded for this legislation yet.
Related News
2 articlesAdvocacy 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.
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.
Source Information
Document Type
Congressional Bill
Official Title
Biosimilar Red Tape Elimination Act
Data Sources
Sponsor
Cosponsors
(4)Analysis generated by AI. Always verify with official sources.