Health Care: Speeding Up Approval for Lower-Cost Medicines
A senate committee must act next: committee consideration.
The bill has support from both parties in the Senate, which helps its chances. However, many healthcare bills face delays in committee before they can get a full vote.
Scores run from -100 (strongly harmful) to +100 (strongly beneficial) for each group, combining impact, certainty, scope, and duration ratings of 1-5. How impact scoring works
People buying insurance through ACA marketplaces who need biologic drugs for conditions like autoimmune disease could see lower out-of-pocket costs if increased biosimilar competition eventually pushes prices down, though this bill's direct effect is limited to a technical FDA review change.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Senator Ashley Moody (R, Florida) introduced S. 5059 on July 21, a bill to amend the Public Health Service Act to streamline the review of biosimilar biological products. The measure joins other bipartisan efforts to cut drug costs by modernizing the FDA's approval process for lower-cost medicines.
The Expedited Access to Biosimilars Act would codify the FDA's science-based approach to biosimilar review by limiting comparative efficacy studies. The bipartisan legislation aims to reduce unnecessary regulatory barriers and bring lower-cost prescription drugs to patients faster.
Proposals in the House and Senate, both titled the Expedited Access to Biosimilars Act, seek to reduce the cost of biosimilar development by removing the mandate for late-stage clinical efficacy trials. The bills would codify regulatory changes to the 351(k) biosimilar pathway.
No votes or related bills recorded for this bill yet.
Document Type
Congressional Bill
Official Title
A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.
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