Increasing Access to Biosimilars Act of 2023

12/21/2024, 9:05 AM

Increasing Access to Biosimilars Act of 2023

This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of biosimilars under Medicare. Specifically, under the demonstration project, participating providers receive an additional payment based on the difference between the costs to the provider of furnishing the biosimilar and the cost if the provider had furnished the underlying reference biological product instead.

Bill 118 hr 1352, also known as the Increasing Access to Biosimilars Act of 2023, aims to improve access to biosimilar medications in the United States. Biosimilars are biological products that are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic medications.

The bill seeks to increase competition in the biologics market by streamlining the approval process for biosimilars and reducing barriers to entry for manufacturers. This would help lower costs for patients and increase access to life-saving medications.

Key provisions of the bill include: 1. Allowing biosimilar manufacturers to rely on FDA-approved reference products for certain data, reducing the time and cost of development. 2. Establishing a pathway for interchangeable biosimilars, which can be substituted for the reference product without the intervention of a healthcare provider. 3. Providing incentives for healthcare providers to prescribe biosimilars, such as reimbursement incentives and education programs. 4. Improving transparency and communication between the FDA, manufacturers, and healthcare providers to ensure the safety and efficacy of biosimilars. Overall, the Increasing Access to Biosimilars Act of 2023 aims to promote competition, lower costs, and increase access to biosimilar medications for patients in the United States.
Congress
118

Number
HR - 1352

Introduced on
2023-03-03

# Amendments
0

Sponsors
+5

Variations and Revisions

3/3/2023

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

Increasing Access to Biosimilars Act of 2023

This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of biosimilars under Medicare. Specifically, under the demonstration project, participating providers receive an additional payment based on the difference between the costs to the provider of furnishing the biosimilar and the cost if the provider had furnished the underlying reference biological product instead.

Bill 118 hr 1352, also known as the Increasing Access to Biosimilars Act of 2023, aims to improve access to biosimilar medications in the United States. Biosimilars are biological products that are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic medications.

The bill seeks to increase competition in the biologics market by streamlining the approval process for biosimilars and reducing barriers to entry for manufacturers. This would help lower costs for patients and increase access to life-saving medications.

Key provisions of the bill include: 1. Allowing biosimilar manufacturers to rely on FDA-approved reference products for certain data, reducing the time and cost of development. 2. Establishing a pathway for interchangeable biosimilars, which can be substituted for the reference product without the intervention of a healthcare provider. 3. Providing incentives for healthcare providers to prescribe biosimilars, such as reimbursement incentives and education programs. 4. Improving transparency and communication between the FDA, manufacturers, and healthcare providers to ensure the safety and efficacy of biosimilars. Overall, the Increasing Access to Biosimilars Act of 2023 aims to promote competition, lower costs, and increase access to biosimilar medications for patients in the United States.
Alternative Names
Official Title as IntroducedTo require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

Policy Areas
Health

Potential Impact
Congressional oversight
Government studies and investigations
Health care costs and insurance
Medicare
Prescription drugs

Comments

APPROVED
EK
Eric Kenney
@celery_seed_lochside_quince92500
This bill is a total disaster! It's gonna screw us over big time. Can't believe they're even considering passing it. So frustrating!

Recent Activity

Latest Summary4/4/2023

Increasing Access to Biosimilars Act of 2023

This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of b...


Latest Action12/17/2024
Referred to the Subcommittee on Health.