FDA kicked off reauthorization negotiations for the Biosimilar User Fee Act (BsUFA) in December 2015, when the first public meeting was held on the subject. More recently, FDA met with various industry professionals last month to discuss various topics regarding the negotiations. The meeting, which took place in mid-March 2016, was held in order to:
FDA started out the meeting with an overview of the statutory provisions for the BsUFA reauthorization process. Also at the meeting’s outset, the Agency presented a proposed timeline for the negotiations’ completion. Industry parties responded to this timeline with “an estimate of the time needed for their respective organizations to review a draft package of proposed recommendations following the face-to-face negotiations, to further inform the development of a timeline for future discussions.”
During the meeting, FDA outlined its experiences during the first three years of BsUFA and highlighted its goals and enhancements for the reauthorization of BsUFA II, which were backed with summaries of the associated proposals. Among these goals, FDA included:
Industry representatives also provided their perspectives for the reauthorization of BsUFA II, which include:
Biotechnology Industry Organization (BIO) & Pharmaceutical Research and Manufacturers of America (PhRMA) [presented jointly] –
In response to these perspectives, FDA asked the industry parties to coordinate their respective proposals in order to develop one unified set. The Agency asked that this be done by the time of the group’s next meeting.
During the meeting, attendees also worked to establish a set of ground rules to govern the BsUFA reauthorization negotiations. At this time, FDA proposed a set a rules, which were agreed upon by everyone in attendance. Nonetheless, “it was acknowledged that the more detailed discussion surrounding any of the original high-level proposals may warrant introduction of new components under such proposals at a later date.”
At the close of the discussion the next meeting was set, which was scheduled to be held on March 24, 2016. FDA has not yet published any information regarding the events of the arranged meeting. It will be very interesting to watch as FDA continues to progress through the BsUFA II reauthorization negotiations, especially with the Agency’s recent approval of Inflectra™ (infliximab-dyyb), the second US biosimilar product.
Our regulatory group specializes in all things pertaining to an FDA submission and can help get your product approved by the Agency in the most time and cost effective manner. To learn more about our services, contact us today.
November 11, 2015
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
August 22, 2019
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
February 21, 2017
On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.” regarding its bioequivalence recommendations for the product. In the revised...