FDA's Public Hearing on Biosimilar Action Plan Draws Wide Stakeholder Involvement

The FDA held a public hearing today at its White Oak Campus in Silver Spring, Maryland, to hear industry and other stakeholder comments regarding the Biosimilar Action Plan (BAP) that was released in July 2018. The public hearing incorporated comments from 27 speakers and was presided over by a panel of FDA and the Center for Drug Evaluation and Research (CDER) representatives.

Along with its announcement of this public hearing, the FDA provided 9 questions that they would like further industry input on, including how the agency can help biosimilars and interchangeable products reach patients more quickly, what additional information or features can be incorporated into the Purple Book to make it more useful to stakeholders, and how the agency can ensure that confidence in biosimilars among patients, healthcare providers, pharmacists, and other stakeholders continues to grow.

Read more about the Biosimilar Action Plan.

A common theme reiterated throughout the meeting from all sides of industry was concern about the potential for a patient who had been administered a single biosimilar product deemed interchangeable to its reference product being substituted at the pharmacy level for another interchangeable biosimilar, though neither biosimilar has been scientifically proven to be interchangeable with the another.

Nathan Doty, associate director of biotherapeutics regulatory affairs at AbbVie, was one stakeholder who raised this concern, stating that “Substitution between interchangeable biosimilars of the same reference is not scientifically justifiable,” and stressed that the problem could become more compounded as more and more interchangeables eventually come onto the market.

Conversely, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology’s (ACR) Government Affairs Committee, spoke in support of the interchangeability draft guidance document put forward by the FDA, and said that ACR strongly supports the robust switching studies required to determine if a biosimilar is indeed interchangeable. He also noted that the protocol, which requires 3 total switches, is a reasonable attempt to simulate what patients would experience in the changing marketplace.

Another aspect commonly discussed by presenters was the overhaul of the Purple Book. “The FDA can and should take steps to make the Purple Book more useful for all stakeholders, by making it available as an interactive, functional, searchable database similar to the Orange Book,” said Juliana Reed, president of the Biosimilars Forum.

In addition to these suggestions, presenters encouraged the FDA to include the patents owned by the reference product developers in the Purple Book as well, similarly to how patents are already listed in the Orange Book. The FDA, while considering the idea, also had questions around whether or not the FDA has this authority.

Patient advocacy groups shared their broad concern for steadily increasing drug prices in the United States, stating that while the administration’s efforts to address drug prices are commendable, more needs to be done in terms of patients sharing in the cost savings. Specifically, Sarah Aoanan, a patient advocate and community outreach manager at the Global Healthy Living Foundation, said, “The price of a drug to a patient is an out-of-pocket cost, not an arbitrary list price…in the case of biosimilars, patients must share in the cost savings.”

Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”

The lack of biosimilar uptake in the marketplace was emphasized by Lisa Skeens, vice president of global regulatory affairs at Pfizer, when she explained that although its infliximab biosimilar, marketed as Inflectra, is sold at an average sales price of 24% lower than that of the reference product, the market share for the biosimilar remains low.

Additionally, a number of presenters continued to take issue with the biosimilar naming guidance that was finalized in early 2017. The guidance dictated that each biosimilar be given a 4-letter suffix, devoid of meaning, and drew concern from various industry members due to the potential for this distinction to make a biosimilar appear as a different or perhaps less clinically effective product than the reference. Numerous stakeholders at the hearing urged the FDA to reconsider this final guidance, and to instead institute a meaningful suffix for these products.

Gottlieb stressed the importance of holding public hearings such as this one to collect feedback from across the industry so as to enable the FDA to learn where they can offer further clarifications and where there remains potential to make certain processes more efficient. Written comments will be accepted after the public hearing until Friday, September 21, 2018 on the Federal Register.