The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.
The Biosimilar User Fee Act of 2012 (BsUFA), which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September. To continue the user fee program and facilitate patient access to safe and effective biosimilar drugs after the 5-year period of the BsUFA, the FDA sought reauthorization of the act under slightly modified terms.
After the FDA held meetings to renegotiate an extension of BsUFA (known as BsUFA II), Senate and House bills to reauthorize user fee programs were passed out of committee in May and June, respectively. The 2 bills will proceed to the House and Senate floors for further debate and possible changes, but the act will need to be authorized before Congress enters its August recess in order to avoid interruptions to the FDA.
In a review of BsUFA II legislation, Aiding Harston of Rothwell, Figg, Ernst & Manbeck, PC highlighted some key differences between the new act and its predecessor. Among the most important considerations for industry include the following:
BsUFA II extends the FDA’s goal time to review and take action on 90% of applications for biosimilars. While BsUFA I set a goal of reviewing and acting on such applications within 10 months of receipt, BsUFA II begins the 10-month clock on the date on which the applicant receives notice that its application has been accepted for review. This change extends the goal action date by 60 days, making the period from application to possible approval 1 year at the earliest. The aim of this extension is to provide more time for communication with the applicant and for inspection of manufacturing facilities.
BsUFA II provides for a new review model that seeks to minimize the number or review cycles needed for approval of a drug, to provide more time and resources to the FDA during the review process, and to facilitate additional communication between the applicant and the agency. While that added communication is welcome news to applicants, the new protocol also seeks to deliver more information to other stakeholders. The plan will allow for greater distribution of information to the public to improve understanding of biosimilars, clarify regulations for all biosimilar developers, and deliver more information related to dates of patent exclusivity for reference products.
BsUFA requires the FDA to publish revised draft guidance on its Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants and to update draft guidance on Brest Practices for Communication Between IND Sponsors and FDA During Drug Development in 2018, as well as to publish draft guidance—some of which it has published already—on a range of topics, including interchangeability, clinical pharmacology data to support biosimilarity, nonproprietary naming of biologics, statistical approaches to evaluate analytical similarity, processes and considerations related to post-approval manufacturing changes for biosimilars, and labeling for biosimilars.
BsUFA II drastically increases the fee amounts. Under BsUFA II, base user fees are set to generate $45 million in revenue by 2018 (an increase of 125% on revenue in 2017). However, the Trump Administration’s budget proposes even further increases; with HHS cuts estimated at $15.1 billion, the Trump budget would compensate for such cuts by requiring industry fees to fund 100% of costs for the premarket review and approval of biosimilars.
Thus far, the committees that have passed the bipartisan House and Senate bills to renew biosimilar user fees have been reluctant to embrace the administration’s requests, and even more reluctant to entertain the idea of renegotiating user fees that were arrived at through the lengthy series of FDA meetings.
As the Regulatory Affairs Professionals Society pointed out in April, if Congress does not reauthorize the BsUFA and other user fee legislation prior to August, the FDA could be forced to lay off more than 3000 workers, significantly hampering the organization’s ability to approve new drugs in a timely fashion.