BIOSIM Act

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.

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.