Should FDA Be Solely To Blame For Slow BPCIA Formation?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

In recent weeks, the Committee on Energy and Commerce’s Subcommittee on Health held a hearing to discuss the progress being made on the implementation of the Biologics Price Competition and Innovation Act (BPCIA). Their guests of honor included the FDA’s director of Center for Drug Evaluation and Research (CDER), Janet Woodcock, and the Centers for Medicare & Medicaid Services’ (CMS) Sean Cavanaugh. The highlight of the hearing was the questions about congressional funding directed toward Woodcock from Rep. Frank Pallone of New Jersey, to which Woodcock revealed there had been no congressional funding provided early in the formation of the BPCIA. This lack of funding could certainly explain the slow formation of the regulatory pathway today. However, overall, this hearing continued to emphasize the lack of transparency over what else might be stalling the development of this pathway five years after the approval of the BPCIA.

As was revealed through Pallone’s questioning, the FDA was not granted any appropriations from Congress for the development of the BPCIA following its approval in 2010. The Biosimilar User Fee Act (BsUFA) was launched in 2012 to provide funding. These fees are then put toward hiring staff and putting in place the processes needed to review and approve biosimilars. As the agency did not receive additional appropriations from Congress, the FDA was required to reallocate $20 million from a variety of different activities, such as compliance activities, to form the base funds for the implementation of the BsUFA.

When asked by Pallone if this lack of funding has made it difficult for the FDA to increase review time lines and educate the necessary parties, Woodcock acknowledged that, while “what has been is water under the bridge,” more funding at the launch of the BPCIA would have helped establish a more fully formed pathway today. The FDA is seeing increasing funds from the BsUFA. As Woodcock outlined, in 2013, the FDA received $6 million. This number increased to $13 million in 2014, and last year hit $23 million.

Her concern now, however, is that the program is going to “explode.” As more players look to compete for a share of the biosimilar market and the volume of applications continues to increase, Woodcock is concerned the FDA “will not have the staff because we are always waiting to catch up.” However, when asked directly if the FDA needed more appropriations from Congress to ensure the BPCIA would take shape more quickly, Woodcock was unable to comment.

After all the criticism and concern from members of Congress lately about the time it’s taking to solidify the pathway, it was surprising to hear about this lack of initial funding. 2015 was clearly the year that drug pricing reached a pitch among consumers and payers, though biologics have been on the rise for years. The formation of the BPCIA in 2010 clearly reveals the need for cheaper biologics. Therefore it’s frustrating, to say the least, that no appropriations were provided to speed the development of this important pathway for more cost-effective biologics — especially given the EU’s success with biosimilars. This revelation was enough to make me question whether the FDA is solely to blame for how slowly the pathway is coming together.

Agency Transparency Still A Barrier

The FDA has been earning millions in user fees from biosimilar companies over the past few years. In the grand scheme of things for pharma, $23 million is a small chunk of change. But it’s also $10 million more than the FDA made from user fees in 2014. The U.S. is facing the release of its second biosimilar onto the market, and three key guidances still have yet to be released — and indeed don’t have a concrete release date — 5+ years after the BPCIA’s formation.

The BsUFA Workload Volume & Cost: Interim Report was released last August to provide details about the workload behind establishing resources for the industry, reviewing biosimilar applications and manufacturing facilities, and post-market safety activities, among other things. (The final report will not be officially published until September of this year.) This report shows that the FDA spent roughly $20.9 million in the first two quarters of 2015 alone on biosimilar-related work. In 2013, the agency spent roughly $23.6 million, and $21.4 million in 2014. For just half of 2015, the agency was closing in on the total spent in the whole of 2014. It’s information like this, however, that does not often get circulated. Even though this 56-page report exists, there was never any mention of figures such as these in the hearings. Nor does it seem the FDA has been particularly vocal about how participating biosimilar makers’ user fees are being allocated. Indeed, the BsUFA was launched to help the FDA put necessary biosimilar processes in place (*cough* publishing guidances *cough*). However, the industry has yet to receive the FDA’s ideas on several highly important processes. Nor have industry players really heard detailed reasons as to why this information has been stalled. As such, companies are likely wondering just how their fees are being used in the development of — or lack thereof — the BPCIA pathway.

In fact, rather than emphasizing the ways these funds are being distributed or in what ways they are not succeeding in helping the FDA accomplish key BPCIA tasks, the FDA chooses to rely on very generalized terms. One committee member said it best when he described this recent hearing as being a “30,000-foot CliffsNotes discussion” on the differences among generics, biosimilars, and biologics. In fact, it seemed as though the hearing was dominated by the familiar and tired acknowledgement that biosimilars are A. not generics, B. will never be identical to the reference product (or each other), and C. may not have the same safety profile as the reference product for all indications. But with reference makers and the FDA continuing to say these words, this phrasing is starting to feel like a crutch. The industry is more than aware there needs to be some caution establishing a biosimilar regulatory pathway, especially for the more complex biosimilars that are being released onto the market. Biosimilar mAbs, such as AbbVie’s Humira, don’t have years-worth of data on the European market to prove and reassure U.S. regulators of their safety and efficacy. Therefore, establishing a way to approach them from a regulatory standpoint will take time.

However, based on the questions asked at this last meeting, even committee members who are not pharmaceutical experts demonstrated they are at least aware that biosimilars are different and much more complex than generics. Therefore, the more biosimilar complexity and “bulletproof science” is pegged as the reasons the FDA has been slow to define the BPCIA pathway, the more it becomes apparent this is not the level of transparency the industry is asking for or needs.