The Alliance for Health Reform recently held a briefing on biologic drugs and the emerging market for biosimilar products in the United States. The briefing allowed for a discussion of regulatory and policy questions that continue as the Food and Drug Administration (FDA) continues to review and approve applications for biosimilars. As of right now, the FDA has approved two biosimilars, but only one of those two approvals is available on the market.
The panel discussion included experts such as: Leah Christl, the associate director for therapeutic biologics at the FDA; Barbara Finck, the chief medical officer at Coherus Biosciences; Brian Lehman, the manager of pharmacy benefits and policy at the Ohio Public Employees Retirement System (OPERS); Leigh Purvis, director of health services research at AARP; and Angus Worthing, rheumatologist and member of ACR Government Affairs Committee, American College of Rheumatology.
Panelists represented a wide range of stakeholders and throughout the discussion, panelists talked about public acceptance of biosimilars, the costs of biosimilars (as well as potential for savings), and lingering regulatory issues such as standards for interchangeability and non-proprietary naming requirements.
Leah Christl discussed what type of data will be necessary to demonstrate a biosimilar's interchangeability with its reference product. She noted that we are dealing with uncharted waters here, as the United States is the only country to actually differentiate between biosimilarity and interchangeability. She stated that interchangeability is a different standard, but not necessarily a higher standard. She, however, stopped short of giving specific data elements that will be required, noting that no guidance has yet been published.
She offered the suggestion to look to the statute, to see the types of information that might be necessary. She further noted that the information did not have to necessarily be clinical data, and can include elements from post-market analysis. The agency will consider the "totality" of the circumstances, avoiding a "one size fits all" approach.
FDA Regulatory Efforts
While it may seem like it is taking a long time for the FDA to do much of anything about biosimilars, it is important to remember that there are several pieces to the puzzle that need to be put together. According to Dr. Worthing, full transparency is key: it will allow patients to know what they are taking and will provide physicians with the information they need to know about what they're prescribing. He believes that "this can be accomplished by using distinct names for biosimilars, having clear information on FDA drug labels, and implementing consumer-oriented pharmacy dispensing practices."
Barbara Finck spoke on biosimilar development, acknowledging that biosimilars have the same amino acid "backbone" as their reference drug, but as they are made of living cells, they have small differences as a result of manufacturing. Dr. Finck equated it to an expert forger making copies of the Mona Lisa, each copy would be very good, but there would still be small differences between the copy and the original; Dr. Christl equated it to brewing beer: the fermentation process can render each batch slightly different that the one before it, even though they always start with the same ingredients.
Public Acceptance of Biosimilars
The panelists generally discussed how important it is for the biosimilar market to be thriving: Leigh Purvis noted that it may be important for patients to fully understand that there is nothing to fear about biosimilars, and that they would (on average) save patients 25% to 30% as opposed to the reference product. Biosimilars, therefore, may be a solution to the contentious drug pricing topic frequently discussed these days.
Dr. Finck also agreed that biosimilars are safe and effective: she referenced stringent FDA statistical standards and the European experience. Biologics and biosimilars are expected to be covered under Part D.
In the end, Dr. Worthing noted, "It's easy to get lost in the weeds of regulatory issues, but biosimilars naming, labeling and interchangeability issues have real and profound safety and health consequences for patients."