BIOSIM Act

3/8/2023, 7:58 PM

Summary of Bill HR 2815

Bill 117 HR 2815, also known as the Biosimilar Innovation and Patient Safety Act, is a piece of legislation introduced in the US Congress. The main goal of this bill is to promote the development and approval of biosimilar drugs, which are lower-cost alternatives to biologic drugs.

The bill aims to streamline the approval process for biosimilar drugs by providing a clear pathway for their development and ensuring that they meet the same safety and efficacy standards as their biologic counterparts. This is intended to increase competition in the pharmaceutical market and lower drug prices for consumers.

Additionally, the Biosimilar Innovation and Patient Safety Act includes provisions to enhance patient safety by requiring that biosimilar drugs have distinct names and labeling from their reference biologic drugs. This is to prevent confusion among healthcare providers and patients and ensure that the appropriate drug is being prescribed and administered. Overall, the Biosimilar Innovation and Patient Safety Act seeks to promote innovation in the pharmaceutical industry, increase access to affordable medications for patients, and improve patient safety through clear labeling and regulation of biosimilar drugs.

Congressional Summary of HR 2815

Bolstering Innovative Options to Save Immediately on Medicines Act or the BIOSIM Act

This bill increases Medicare payments for biosimilars for five years. The bill applies to biosimilars for which the average sales price or wholesale acquisition cost is less than that of the reference biological product, as specified.

Current Status of Bill HR 2815

Bill HR 2815 is currently in the status of Bill Introduced since April 22, 2021. Bill HR 2815 was introduced during Congress 117 and was introduced to the House on April 22, 2021.  Bill HR 2815's most recent activity was Referred to the Subcommittee on Health. as of April 23, 2021

Bipartisan Support of Bill HR 2815

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
8
Democrat Cosponsors
6
Republican Cosponsors
2
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 2815

Primary Policy Focus

Health

Potential Impact Areas

Health care costs and insuranceMedicarePrescription drugsProduct development and innovation

Alternate Title(s) of Bill HR 2815

BIOSIM ActTo amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.BIOSIM ActBolstering Innovative Options to Save Immediately on Medicines Act
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