Biosimilar User Fee Act (BsUFA) | Association for Accessible Medicines

GDUFA and BsUFA User Fees

Submitted by eklinger on Fri, 06/03/2022 - 11:48

What are GDUFA and BsUFA user fees? Watch this this video to learn more about how the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) help to get more generic and biosimilar medicines to patients more quickly. Over ten years, the generic and biosimilar industry has provided the FDA over $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients and a dramatic increase in patient access to life-saving treatments.

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AAM Statement on FDA User Fee Reauthorization

WASHINGTON D.C. (February 2, 2022) – AAM strongly supports congressional reauthorization of GDUFA and BsUFA as negotiated and without changes. Timely approval of the FDA user fee agreements will ensure that patients continue to benefit from new, more affordable generic and biosimilar medicines. GDUFA III and BsUFA III are the culmination of months of negotiations, have been subject to public review and comment, and represent a careful balance between stakeholders.

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BsUFA Reauthorization: A Primer

The Biologics Price Competition and Innovation Act of 2010 (BPCIA) created FDA’s biosimilar approval pathway. The first biosimilar was approved in 2015. As of January 2022, there are more than 30 FDA-approved biosimilars with dozens more in the queue. The Biosimilar User Fee Act (BsUFA) is a law authorizing FDA to assess and collect fees from drug manufacturers that submit BLAs for FDA’s review and approval.

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