Source: BsUFA Reauthorization Negotiations Are Complete

The FDA and industry have successfully negotiated terms for renewing BsUFA, a source familiar with the matter tells Generic Line.

The source, who declined to speak on the record about the subject, declined to divulge particulars about the terms of the deal, citing a gag order.

FDA spokesman Kris Baumgartner declined to address the source’s claim that the two sides have settled on a draft commitment letter addressing negotiations. Instead, he said that the whole process has not been completed, but that the talks are “well advanced.”

Negotiations for reauthorizing BsUFA before the user fee program expires in September 2017 have been back and forth for months, with 14 meetings between March and May.

Lynn Blenkhorn of the Biosimilars Forum, one of the four industry organizations taking part in the negotiations, confirmed that “there is an agreement” and that “all parties are satisfied with the outcome.”

One of the most recent Steering Committee meetings — which took place on May 12 — involved discussions about a proposal to establish a written response only-option for certain FDA-sponsored meetings.

Another series of meetings were scheduled for May 18 to May 19, although the FDA has yet to post minutes from those sessions. — Michael Cipriano and José Vasquez



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