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
Those comments are expected to shape a final FDA recommendation on biosimilar user fees, which the agency plans to send to Congress by January 15, 2012. On December 7, the agency published “Biosimilar Biological Product Authorization Performance Goals and Procedures, Fiscal Years 2013 through 2017.”
The agency noted, “The proposed biosimilars user fee program for FYs 2013 through 2017 addresses many of the top priorities identified by public and industry stakeholders and the most important challenges identified within FDA.”
Companies aren’t expected to disagree too much with the framework, which was developed by FDA, representatives from several biopharma companies, the Biotechnology Industry Organization (BIO), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
“PhRMA supports the development of a robust user fee program for biosimilar products to provide FDA with the resources needed to review biosimilars without diverting resources from the review of innovative medicines,” Matthew Bennett, an svp with the organization, told GEN.
The user fee program is expected to aid FDA in developing the final abbreviated approval pathway for biosimilars, which was required under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. BPCIA was tucked into page 686 of the Patient Protection and Affordable Care Act enacted last year by President Obama. Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research co-authored a paper published this August in The New England Journal of Medicine that provided some clues on the overall approval pathway.
User fee funding would supplement dedicated nonuser fee funding to ensure sufficient resources for the agency’s biosimilars review program. In each fiscal year, in order to spend biosimilar user fees, FDA would be required to have available and allocate at least $20 million, adjusted for inflation, in nonuser fee money for biosimilar review activities. In FY 2011, FDA received an appropriation of $1.8 million plus the use of four full-time staffers for biosimilar product review. Hence, the agency is proposing a phased approach to implement performance goals for biosimilars, commensurate with the availability of additional funds to increase staffing and program review capacity.
“We recognize FDA having adequate dedicated and independent resources to devote to meeting with biosimilar sponsors and timely review of those applications will help ensure successful implementation,” Andrew Emmett, BIO’s managing director of science and regulatory affairs, explained.