On September 13, 2016, FDA announced that it will hold a public meeting on October 20, 2016, from 9 a.m. to 2 p.m. at the FDA White Oak Campus in Silver Spring, Maryland, to discuss recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) through 2022. The meeting will include a presentation by FDA and panels representing stakeholder groups. Other organizations will have an opportunity to present or to submit written comments to the docket prior to the meeting.
The BsUFA authorizes FDA to collect user fees from drug companies that submit marketing applications for biosimilars to fund the process for reviewing biosimilars. It was first enacted in 2012 for a period of five years. The BsUFA is designed to generate additional revenue for the FDA to use in decreasing review time of biosimilars without affecting the quality of the review.
In December 2015, FDA had an initial public meeting that included presentations by FDA and a series of panels representing patient advocates, healthcare professionals, researchers, and the regulated industry, among others. After that meeting, FDA negotiated with the regulated industry to develop recommendations for the reauthorization of the BsUFA. The minutes of these negotiations are available here under the heading “Industry Discussions of BsUFA Reauthorization.”
The October 2016 meeting will provide the public with the opportunity to discuss the recommendations that were developed during the negotiations between FDA and regulated industry that followed the December 2015 meeting. Importantly, these recommendations include new performance goals that FDA must meet in 2018-22 in return for user fees from applicants. These performance goals will replace the original goals that went into effect in 2012. Because the approval process for biosimilars is still in its infancy, the development of additional and more comprehensive performance goals, beyond the initial goals set in 2012, will assist biosimilar manufacturers in planning and developing new products.
In the first five years after the BsUFA was enacted, FDA’s performance goals included reviewing and acting on 90 percent of original biosimilar applications within 10 months of receipt, and reviewing and acting on 90 percent of resubmitted original biosimilar applications within 6 months of receipt by 2017. As of 2014, FDA met or exceeded 11 of 18 performance goals, including the 10-month review goal for original biosimilar applications. Some of the performance goals were not applicable because FDA has not yet received any submissions in certain categories. For example, while FDA received two original biosimilar product applications in 2014, it received no resubmitted original biosimilar applications. Most of the goals FDA failed to meet in 2014 related to responding to meeting requests and scheduling meetings with applicants. In its report for the 2015 fiscal year, FDA stated that it expected to meet or exceed 13 of 18 performance goals. The report states FDA had received five original biosimilar product applications in 2015.
The new performance goals that have been proposed as part of the reauthorization process this year include:
reducing multiple review cycles for biosimilars
allowing an extension to the review period when FDA needs to conduct late inspections of manufacturing facilities
adding pharmacokinetic and pharmacodynamic similarity studies to the types of clinical study protocols that qualify for a Special Protocol Assessment and Agreement under the BsUFA
decreasing review time for biosimilar prior approval manufacturing supplements
creating a mechanism for meetings with sponsors of biosimilar applications
improving FDA hiring and retention of review staff and increasing staff capacity for review and communication
The full recommendations for the BsUFA that will be discussed at the October 20th meeting are available here. We will, as always, continue to monitor and report on any further developments, including following the October 20, 2016, meeting.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes and is not intended to be and should not be taken as legal advice.
Tasha Francis, Ph.D., practices intellectual property litigation with an emphasis on patent litigation. Her clients range from solo inventors and emerging companies in the biotechnology and biopharma industries to established international pharmaceutical companies. She has extensive...