Biosimilar User Fees: FDA and Industry Reach Agreement

Monday, June 27, 2016

Source: RAPS

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May.

Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015.

Similar to FDA's other user fee programs, BsUFA is a five-year agreement between FDA and its stakeholders on a program to fund FDA's review of biosimilar drugs through various fees paid by biosimilar sponsors.

As with other user fee programs, the revenue collected from the fees will be used to support FDA's review program and will be tied to performance goals for the agency.

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