Bill · H.R. 5526· House(119-HR-5526)

Biosimilar Red Tape Elimination Act

Age: 49 years

Texas

Introduced: 9/19/2025
Last activity: 9/19/2025 — Referred to the House Committee on Energy and Commerce.
Sponsored by: August Pfluger
Cosponsors: - 6 - 4

Health

Introduced
In Committee

What this bill would do

The Biosimilar Red Tape Elimination Act aims to change how biological products are determined to be interchangeable with their reference products. Under this bill, a biological product licensed under section 351(k) would be deemed interchangeable with the reference product. This change includes specific timing rules for products licensed before or after a designated transition date. The bill also maintains unexpired exclusivity periods for certain biological products. Additionally, the Secretary is required to update various guidance documents related to biosimilarity and interchangeability.

Yes· 3 of 7

Does this lower the price of prescription medicines?+5
Deeming biological products interchangeable with their reference products aims to facilitate the market entry of more affordable biosimilars.
Would households on low incomes be better off under this?+4
Lower prescription drug costs resulting from increased biosimilar competition may disproportionately benefit low-income households.
Would middle-income households be better off under this?+4
Potential savings on prescription drugs could alleviate financial burdens on middle-income families.