Biosimilar User Fees: FDA and Industry Reach Agreement

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May.

Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015.

Similar to FDA's other user fee programs, BsUFA is a five-year agreement between FDA and its stakeholders on a program to fund FDA's review of biosimilar drugs through various fees paid by biosimilar sponsors.

As with other user fee programs, the revenue collected from the fees will be used to support FDA's review program and will be tied to performance goals for the agency.

Now that the two sides have agreed on the draft commitment letter, the industry groups that participated in the negotiations, the Pharmaceutical Research and Manufacturers of America (PhRMA), Biotechnology Innovation Organization (BIO), Generic Pharmaceutical Association (GPhA) and the Biosimilars Forum, will take the draft agreement to their members to gather support.

"PhRMA, BIO, the Biosimilars Forum, and the Biosimilars Council (GPhA) participated in the BsUFA II FDA-Industry technical negotiations. Once the Obama administration has completed its review, a public meeting notice will be published in the Federal Register and the draft goals letter will be made available for public review and comment," PhRMA spokesman Andrew Powaleny told Focus.

However, Kris Baumgartner, an FDA spokesperson could only confirm that the negotiations are "well advanced," and would not "speculate on the date for reaching completion."

As such, details about the agreement, including the fee amounts, new programs and specific performance goals for FDA, are sparse.

In the most recent meetings, FDA and industry were still in the process of ironing out several aspects of the agreement, according to minutes of the meetings made public by FDA.

While the fees for the next iteration of the program remain secret, both sides have stressed the importance of keeping the fees somewhat stable, while providing sufficient and consistent funding to the agency.

During a finance meeting on 12 May, the two sides discussed "potential enhancements to the user fee structure that could mitigate volatility in FDA funding levels and sponsor fee amounts caused by fluctuations in fee-paying submissions from year-to-year during BsUFA II," according to the minutes.

During the general meeting that day, FDA officials gave their response to industry feedback on its proposal for a review model for biosimilars that would mirror its program for prescription drug review.

Previously, in April, industry said it would support such a program, as long as FDA agreed to meet certain conditions, such as undergoing an interim evaluation to assess the program's performance.

But, given the relatively few biosimilar applications the agency is expected to review in the coming years, both FDA and industry agreed that the timing of such an evaluation would be important "to ensure that a sufficient amount of data would be available and to have the report findings available in time for the negotiations of BsUFA III."

Another point of contention between FDA and industry at the 12 May meeting has to do with who gets to decide whether companies can get to sit down face-to-face with FDA for certain types of meetings. At the meeting, FDA said it wants to be able to send companies a written response in situations when "the questions posted by the sponsor can be sufficiently answered in writing," as the agency can do for prescription drugs.

However, industry said it believes "that only the sponsor should be able to determine the format of the meeting." If industry gets its way, sponsors would be able to request either a face-to-face meeting, a written response from FDA, or both.

Also uncertain is the fate of FDA's proposal for a dedicated biosimilar review unit. During the 12 May meeting, industry requested additional details about how the dedicated unit would be structured, and said it would wait for more information before giving feedback to FDA on the proposal.