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Insight & Intelligence : Dec 16, 2011
FDA Holds Public Discussion of User Fee Program for Biosimilars
Initiative is one step in agency’s road to developing the final abbreviated approval pathway for biosimilars.
More than a year after launching a dialogue with industry regarding biosimilars, FDA is holding a morning-long public meeting today. The proposed approval pathway and fees drug developers must pay for the five fiscal years starting October 1, 2012, will be discussed. The agency is soliciting public comment through January 6, 2012
User Fee Proposals
FDA envisions creating four categories of user fees. The first would be biosimilar product development (BPD) fees, starting when sponsors submit an IND or meet with FDA. The initial fee would be 10% of the fee established for a drug application under PDUFA each year from FY 2013 through 2017. The agency would collect only one initial BPD fee per product, regardless of the number of proposed indications.
In return for collecting user fees, FDA agreed to a series of goals for its review of applications for new and resubmitted biosimilar products. The agency committed to reviewing and acting upon 70% of original and resubmitted biosimilar submissions within 10 months of receipt in FY 2013. That percentage is expected to climb to 80% in FY 2015, 85% in FY 2016, and 90% in FY 2017.
Developing a Biosimilar
FDA has also set performance goals and procedures for meetings related to biosimilar development programs. Following a Biosimilar Initial Advisory Meeting, the agency anticipates holding:
“These meetings relate to sponsors’ biosimilar development programs and are not mandatory,” Mahoney explained. “Sponsors choose the combination of meetings matching their specific development needs.”
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.
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