On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user-fee program for biosimilar biological products for fiscal years 2013–2017. Under the Biologics Price Competition and Innovation Act of 2009, FDA must publish the recommendations for a biosimilars user-fee program in the Federal Register, and provide a period of 30 days for the public to provide written comments on the recommendations. FDA is also required to hold a meeting at which the public may present its views on such recommendations.
The recommendations that will be presented were formulated after a period of consultation and negotiation with members of industry and public stakeholders that occurred between June and September 2011. Stakeholders were asked to consider how a biosimilar fee program should differ from the structure outlined under the Prescription Drug User Fee Act (PDUFA), and whether fees should be used to support postmarketing safety studies.
According to the FDA release, the proposed fee structure is similar to the PDUFA program, in that fee revenues would be used to support marketing applications, manufacturing, and products. In addition, it provides for fees collected earlier in the development process to support a series of biosimilar product-development meetings between sponsors and FDA. As outlined in the FDA release, four types of fees are proposed:
The release also contains an outline of proposed review performance goals and procedures. FDA aims to review 70% of original biosimilar biological product applications within 10 months of the receipt date. A full description of the proposed goals and procedures for the biosimilars user fee program can be found on FDA’s website.
Concerning the draft performance goals, Pharmaceutical Research and Manufacturers of America (PhRMA) vice-president Sascha Haverfield-Gross said in a press release, “The performance goals letter published today demonstrates FDA’s commitment to a science-driven approach for biosimilars. The letter provides for FDA and sponsor meetings for the substantive review of biosimilar development plans. It also includes a special protocol assessment mechanism for clinical trials intended to establish biosimilarity and/or interchangeability with the innovator biologic product. This provision will help to ensure that clinical trials are designed to thoroughly assess the safety and efficacy of biosimilar medicines, in accordance with the FDA’s high regulatory and scientific standards.”