FDA Makes Progress in Biosimilar User Fee Negotiations

April 13, 2016

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:

  • Agree on ground rules and establish a proposed time line governing the negotiations.
  • Allow FDA and industry participants to provide perspectives on BsUFA enhancements.

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:

  • “A negotiation process that supports timely reauthorization;
  • Enhancements to capacity and coordination of review for biosimilars;
  • Enhancements to biosimilar review process communication, consistency and efficiency; and
  • Financial stability for the biosimilar review process with predictability for the FDA and fee-payers.”

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] –

  • “Science-based implementation of the Biologics Price Competition and Innovation Act;
  • An efficient and transparent regulatory process with appropriate timelines, guidance, and feedback to sponsors; and
  • Long-term stability of the BsUFA program through transparent and sustainable financing.”

The Biosimilars Forum

  • “Measures to enhance the soundness and sustainability of the financing model,
  • Enhancement to the exchange of information, and
  • Procedural enhancements.”

Generic Pharmaceutical Association (GPhA) Biosimilars Council

  • “Provided an overview of their enhancement proposals in the areas of
    • Meeting management, meeting performance, application review, policy, fees, education, and other.”

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.

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