The latest user fee program to finish renewal talks is that for biosimilars. FDA and industry officials confirmed that both sides are in the process of ratifying the resulting commitment letter.

Neither FDA nor industry officials would reveal specific details about the agreement, but it appears BsUFA II will incorporate changes to the application review system along with resource improvements for a program that is growing along with the market for biosimilar products in the US.

Leah Christl, associate director for therapeutic biologics in the Office of New Drugs, said June 20 that there will be routine improvements benefiting the process overall, as well as changes improving the review process and financial aspects of the program.

Juliana Reed, Coherus BioSciences Inc. VP of government affairs and president of the Biosimilars Forum, a trade association that participated in the negotiations on behalf of industry, said that the forum was pleased with the agreement and supported it.

Reed said it should give FDA the time to review biosimilar applications and the resources to approve them.

The Forum, along with the Biotechnology Innovation Organization, the Pharmaceutical Research and Manufacturers of America, and the Generic Pharmaceutical Association's Biosimilars Council, represented industry during the talks.

BIO said in a statement that it was "pleased to be part of a group of negotiators who worked together very productively and cooperatively."

Both the application clearance and resource portions of the biosimilar program have been concerning since BsUFA was created in 2012.

In particular, FDA underestimated the number of sponsors that would create biosimilar product development programs, the pre-351(k) application phase that allows the sponsor to meet with FDA and receive advice on a number of issues ([A#14151218004]).

The agency has received at least nine 351(k) applications and approved two. Two more are scheduled to go before an advisory committee in July ([A#14160613001]).

Revenue Fixes Were Discussed

A number of solutions were proposed during the talks to deal with BsUFA financial concerns.

FDA suggested creating a separate user fee and revenue target for biosimilars, rather than continuing to use the prescription drug user fee formula to set the rates ([A#14160502002]).

FDA also wanted changes to the statutory appropriations trigger that governed when it could begin spending user fee revenue.

Under the existing legal language, FDA has been hesitant to spend BsUFA money because it has been unsure, sometimes until near the end of the fiscal year, whether it would spend enough budget authority dollars, i.e. taxpayer funds, to qualify for user fee funding ([A#00160425006]).

Reed said the BsUFA II agreement allows the agency to meet the trigger, but said Congress also needs to create a separate line for biosimilars in FDA's budget to help it more easily access user fee funds.

Review System, Organizational Changes Proposed

Industry and FDA also appear to have agreed to changes in the review system, although it is unclear whether they include a longer application review process. The agency had proposed placing biosimilar applications on a 12-month review cycle similar to the system currently used for NDAs.

Biosimilar applications now require a 10-month clock. While the new system would lengthen the process, it also would allow for mid-cycle communications and meetings between FDA and the sponsor, which could allow minor issues to be resolved without requiring another review cycle ([A#14160422001]).

FDA also proposed creating a dedicated biosimilar unit as part of BsUFA II to provide a central coordination point and focus for important scientific, policy and other issues, as well as improve review consistency ([A#14160512001]).

Talks Were Speedy, Despite Issues Discussed

Given the substantial changes that were discussed, the negotiations moved quickly.

Talks began in March and apparently lasted only about three months. FDA requested at the start that the four industry groups coordinate their proposals as much as possible Also see "Biosimilar User Fee Talks Begin With Industry Negotiating Amongst Itself" - Pink Sheet, 11 April, 2016..

The biosimilar user fee negotiations even lapped discussions of the generic user fee program, which began in October and are still ongoing ([A#14160617002]).

PDUFA renewal negotiations also have concluded ([A#14160226004]).

Next step for the BsUFA agreement is formal sign-off from industry and the agency. BIO indicated that it "will be discussing [the draft agreement] with its regulatory committees and its board over the next several weeks to determine the view of BIO about the outcome of the discussions."

Once the trade groups and FDA sign off on the commitment letter, it must undergo clearance by the Department of Health and Human Services as well as the White House.

Then, FDA must conduct a public hearing and receive comments on the agreement. Once that process is completed, it is forwarded to Congress to be incorporated into legislation.

FDA and industry want the commitment letter sent to Capitol Hill by early 2017 to allow sufficient time for Congress to write and debate the bill. Members will not change the agreement, but will undoubtedly add policy and other changes to the bill.

Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed

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