Gillian Woollett, DPhil, MA, senior vice president of Avalere, recently authored an article suggesting ways that the FDA can facilitate applications and approvals for interchangeable biosimilars.
In the United States, although the FDA has approved 9 biosimilar products to date, thus far, no biosimilar has sought or received an interchangeable designation. This designation would allow for pharmacy-level substitution, subject to state law.
Gillian Woollett, DPhil, MA, senior vice president of Avalere, recently authored an article suggesting ways that the FDA can facilitate applications and approvals for interchangeable biosimilars. Woollett’s suggestions comprise 3 key points: making reference products more readily available for conducting switching studies, applying scientific reasoning and clear international guidance on choosing a reference product, and encouraging the development and approval of all biologics.
According to the FDA’s draft guidance on achieving interchangeability, switching studies must be completed with a US-sourced reference. However, reference product sponsors can be hesitant to make their products available to biosimilar developers in the amounts necessary to administer switching studies. In order to address this issue, Woollett suggests that the FDA publicly reprimand drug manufacturers as well as pharmaceutical supply chain intermediaries that take part in withholding samples.
Furthermore, Woollett suggests that the FDA recognize a single version of a reference biologic that could act as a global reference for all biosimilar development as a way to eliminate costly bridging studies.
Finally, Woollett proposes that the FDA support scientifically meaningful studies that reduce the need for sponsors to generate costly data that are not eligible for regulatory decision-making; the need for confirmatory studies should be questioned, as they can delay access and increase costs.
Woollett’s suggestions are in line with some broader trends in the conversation about biosimilars, interchangeability, and competition; FDA Commissioner, Scott Gottlieb, MD, recently stated in an interview that he sees drug companies “gaming the system to try to block competition” in many ways within the current marketplace, and he wants to “end the shenanigans.” One ways to do so, said Gottlieb, is do away with expensive bridging studies.
The Trump administration has also weighed in on interchangeable biosimilars; in early February, the White House’s Council of Economic Advisors (CEA) called on the FDA to finalize its guidance on demonstrating interchangeability, saying that, “if these guidelines are relatively easy and inexpensive to adhere to, it could spur interchangeable applications and approvals, which could result in more effective competition with the reference biosimilar and lower prices.”
Congress has also been considering ways to address the issue of reference product sponsors withholding samples from biosimilar developers; the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, which has yet to see a vote despite broad bipartisan support, would allow a generic or biosimilar drug developer to bring a civil action against the license holder of a reference drug if the latter declines to make available enough samples for testing as part of generic or biosimilar drug development.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.