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A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.
3/11/2024, 7:03 PM
Summary of Bill S 1522
Bill 118 s 1522, also known as the "Biosimilar Interchangeability Study Act," is a proposed piece of legislation that aims to mandate the Secretary of Health and Human Services to conduct a comprehensive study on the designation of biosimilar biological products as interchangeable.
Biosimilar biological products are medications that are highly similar to already approved biological products, known as reference products. These biosimilars have the potential to provide more affordable treatment options for patients, as they are typically less expensive than their reference products.
The bill seeks to address the issue of interchangeability, which refers to the ability of a biosimilar to produce the same clinical result as the reference product in any given patient. This designation is important because it allows pharmacists to substitute a biosimilar for the reference product without the need for additional approval from a healthcare provider. The study mandated by this bill would evaluate the current process for designating biosimilar products as interchangeable, including the criteria used to make this determination. It would also assess the impact of interchangeability on patient access to affordable medications and the overall healthcare system. Overall, the Biosimilar Interchangeability Study Act aims to provide valuable information to policymakers and stakeholders on the effectiveness of the current interchangeability designation process and potential improvements that could be made to ensure patients have access to safe and affordable biosimilar medications.
Biosimilar biological products are medications that are highly similar to already approved biological products, known as reference products. These biosimilars have the potential to provide more affordable treatment options for patients, as they are typically less expensive than their reference products.
The bill seeks to address the issue of interchangeability, which refers to the ability of a biosimilar to produce the same clinical result as the reference product in any given patient. This designation is important because it allows pharmacists to substitute a biosimilar for the reference product without the need for additional approval from a healthcare provider. The study mandated by this bill would evaluate the current process for designating biosimilar products as interchangeable, including the criteria used to make this determination. It would also assess the impact of interchangeability on patient access to affordable medications and the overall healthcare system. Overall, the Biosimilar Interchangeability Study Act aims to provide valuable information to policymakers and stakeholders on the effectiveness of the current interchangeability designation process and potential improvements that could be made to ensure patients have access to safe and affordable biosimilar medications.
Congressional Summary of S 1522
This bill requires the Food and Drug Administration to report on its designation of biosimilars as interchangeable, including the applicable standards, authorities, evidence, and other factors involved in such designations. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.)
Read the Full Bill
Current Status of Bill S 1522
Bill S 1522 is currently in the status of Bill Introduced since May 10, 2023. Bill S 1522 was introduced during Congress 118 and was introduced to the Senate on May 10, 2023.  Bill S 1522's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of May 10, 2023
Bipartisan Support of Bill S 1522
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 1522
Primary Policy Focus
HealthAlternate Title(s) of Bill S 1522
A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.
A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.
Comments
Sponsors and Cosponsors of S 1522
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