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U.S. Department of Health and Human Services

For Industry

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BsUFA Authorization


On March 23, 2010, President Obama signed into law the Affordable Care Act. The Affordable Care Act contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service (PHS) Act and other statutes to create an abbreviated approval pathway for biosimilar and interchangeable biological products. Section 351(k) of the PHS Act, added by the BPCI Act, allows a company to submit an application for licensure of a biosimilar or interchangeable biological product. The BPCI Act directs FDA to develop recommendations for a user fee program for 351(k) applications for fiscal years 2013 through 2017. In developing recommendations for the Biosimilar User Fee Act (BsUFA), FDA consulted with regulated industry and public stakeholders, published the recommendations in the Federal Register, and held a public meeting to review the recommendations. The recommendations were transmitted to Congress on January 13, 2012, and BsUFA was enacted on July 9, 2012. 

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