Biosimilar Red Tape Elimination Act

Hozzl · 2024-03-13T10:02:33Z

Explore the details of Senate Bill 2305 Biosimilar Red Tape Elimination Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

3/13/2024, 10:02 AM

Summary of Bill S 2305

Bill 118 s 2305, also known as the Biosimilar Red Tape Elimination Act, aims to streamline the approval process for biosimilar drugs in the United States. Biosimilars are biologic products that are highly similar to, and have no clinically meaningful differences from, an existing FDA-approved biologic product.

The bill seeks to reduce the regulatory burden on biosimilar manufacturers by allowing them to rely on the FDA's previous findings of safety and efficacy for the reference product. This would eliminate the need for redundant clinical trials and studies, ultimately speeding up the approval process for biosimilars.

Additionally, the Biosimilar Red Tape Elimination Act would require the FDA to provide clear guidance to manufacturers on the requirements for demonstrating biosimilarity. This would help to ensure that the approval process is transparent and efficient. Overall, the goal of this legislation is to promote competition in the biologics market, which could lead to lower prices for patients and increased access to life-saving medications. By reducing unnecessary red tape and streamlining the approval process for biosimilars, the Biosimilar Red Tape Elimination Act aims to benefit both patients and manufacturers in the United States.

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Current Status of Bill S 2305

Bill S 2305 is currently in the status of Bill Introduced since July 13, 2023. Bill S 2305 was introduced during Congress 118 and was introduced to the Senate on July 13, 2023. Bill S 2305's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of July 13, 2023

Bipartisan Support of Bill S 2305

Total Number of Sponsors

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Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

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Policy Area and Potential Impact of Bill S 2305

Primary Policy Focus

Health

Alternate Title(s) of Bill S 2305

Biosimilar Red Tape Elimination ActBiosimilar Red Tape Elimination ActA bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product.

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