• Safi Bello

How To Guide For: Understanding What The Biosimilar User Fee Act Is

The Biosimilar User Fee Act (BsUFA) is critical to supporting the U.S. Food and Drug Administration (FDA) in its core mission of protecting public health. Since its creation in 2012, BsUFA has helped benefit patient safety and public health as biosimilar products are required to meet FDA's high standards for safety, purity and potency. The BsUFA II Agreement will help provide the FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients. On Thursday October 20th, 2016 biosimilar experts, industry representatives and U.S. Food and Drug Administration officials had a meeting to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. According to Reuters -- 19 Democratic senators want Trump to go after rising drug prices. The 19 senators named five areas for cooperation: allowing the Medicare program to negotiate prescription prices, increasing transparency, stopping abusive pricing, passing reform on incentives for innovation and supporting generic competition for branded drugs. These are really important areas that need to be addressed. To learn more about the Biosimilar User Fee Act click on the pictures below to read the articles.

FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US - Read More from U.S. Food & Drug Administration
New "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic Drugs - Read More from FDA
BsUFA Fees, Exceptions, Waivers, and Refunds - Read More from FDA
BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022 - Read More from Regulatory Affairs Professionals Society
Biosimilar User Fee Act (II) Performance Goals Letter Issued - Read More from Policy and Medicine

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