Before industry trade groups can start negotiating with FDA on reauthorization of the biosimilar user fee program in earnest, they may first have to compromise on a common set of changes amongst themselves.

As part of the first negotiating session, the industry representatives present, which included four representatives from the Pharmaceutical Research and Manufacturers of America, four from the Biotechnology Innovation Organization, two from the Biosimilars Forum, and five from the Generic Pharmaceutical Association's Biosimilars Council, appeared to offer diverse and sometimes opposing opinions on policy issues as each group gave an overview of its goals.

The minutes of the March 17 meeting did not provide many details on the changes each group hoped to make in BsUFA II, but they were clear that FDA did not want to negotiate against four separate agendas.

"FDA requested that the industry parties work to coordinate their enhancement proposals to develop a unified set to the extent possible to facilitate FDA-industry discussions in future meetings," the agency said in the minutes.

FDA's request for a united industry front is not new to a user fee renewal process, but the industry negotiation teams find themselves in a unique position representing innovator and biosimilar sides of the sector.

It may prove difficult for them to agree on one set of changes, but consolidating several stakeholder points of view is not a new problem for BsUFA. When FDA began negotiating the first BsUFA agreement in 2011, it allowed any industry member interested to sit at the table Also see "Biosimilar User Fee Negotiations Under Way; Timetable Compressed" - Pink Sheet, 4 July, 2011..

Partnering Has Begun

In a general sense, the four groups appear to have identified many of the same issues for discussion.

BIO and PhRMA already appear partnered for the negotiations. The groups jointly presented their goals, which included "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, an association of brand and generic companies interested in the sector, said it supported "the proposals mentioned by the other parties" and wanted to "enhance the soundness and sustainability of the financing model," as well as improve information exchange and make procedural improvements. The Forum was created 2015 after a public fight among industry stakeholders over state biosimilar substitution laws Also see "Biosimilars Forum: How Do You Create A Brand-Generic Coalition? Don’t Talk About Naming" - Pink Sheet, 11 May, 2015..

The Biosimilars Council, which GPhA launched in 2015, said it wanted to improve meeting management and performance, application review, policy, fees, and education. The Council is part of a new GPhA division focused on biosimilars that is separate from its small molecule generics section ([A#14150210006]).

Will BsUFA Continue Following PDUFA?

FDA intends to deal with workload concerns and program financing in BsUFA II. The agency "highlighted the novel and complex nature of issues involved with biosimilar product development from a technical perspective" and said the "challenges associated with this novelty and complexities were compounded by a greater than expected biosimilar-related workload," according to the minutes.

Center for Drug Evaluation and Research Director Janet Woodcock also warned Congress that the program could "explode" from the workload and lack of resources ([A#14160204002]).

FDA staff engage in a number of activities and meetings with sponsors before a marketing application is filed, in addition to writing guidance and reviewing product applications, which likely is overwhelming staff. One of the answers may be to adjust the biosimilar user fee, which has been tied to NDA charges, but also is structured to create a funding base before a 351(k) is filed ([A#00151102001]).

Indeed, FDA listed "financial stability for the biosimilar review process with predictability for the FDA and fee-payers" among its goals for BsUFA II. It also wants "enhancements to capacity and coordination of review for biosimilars" and improved biosimilar review process communication, consistency and efficiency, according to the minutes.

Among the complaints from industry about the rollout of FDA's biosimilar program was the lack of guidance on important issues. The agency recently put out long-awaited draft guidance on biosimilar labeling ([A#14160331004]). But sponsors still await guidance on interchangeability.

While several biosimilar applications have been submitted for review, many of them appear to have been delayed. The agency on April 5 approved only its second 351(k) application, Celltrion Inc.'s Inflectra (infliximab-dyyb) ([A#14160405006]).

Clock Ticking On Last User Fee Package

BsUFA is the final drug- and biologic-related user fee to begin renewal discussions, leaving FDA and industry with limited time to iron out any differences. Prescription drug user fee reauthorization discussions are finished ([A#14160226004]) and generic drug user fee discussions have been ongoing for months ([A#00160411013]).

New commitment letters outlining the changes for the five-year cycle beginning in October 2017 are scheduled to reach Congress by January in order be incorporated into must-pass legislation. Before getting to Capitol Hill, they must be approved by HHS and the White House, and FDA must conduct public hearings on them.

Biosimilar User Fee Talks Begin With Industry Negotiating Amongst Itself

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