As cost of insulin continues to rise by 15% to 17% annually, concerns have been raised about access to the lifesaving drug that 7 million patients with diabetes rely on every day. In response to these concerns, the US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released a statement outlining the agency’s efforts to combat rising insulin prices by transitioning the approval pathway for insulin biosimilars.
Insulin has historically been regulated under the Federal Food, Drug, and Cosmetic Act, which has made it difficult to bring generic insulin to market given the complexities of biologic products, lack of framework outlining product development, and no clear approval pathway for biologic competition.
In recent months, the FDA has set out to advance policies to promote competition by transitioning products like insulin to be licensed as biologics under the Public Health Service Act, which governs most FDA biologic product approvals. By doing so, the agency expects the more robust approval pathway will encourage development of insulin alternatives by industry sponsors, thereby introducing lower-cost biosimilars and interchangeable insulins to the market.
The transition of insulin products to the biosimilars pathway follows the agency’s other work to encourage biosimilar innovation and competition, including an outline of biosimilar policy framework, an updated policy on naming convention, and a partnership with the Federal Trade Commission.
Ahead of the 2020 transition, the Commissioner also announced a public hearing to discuss affordable insulin products with stakeholders, including the evaluation process for data and other information submitted by applicants seeking to use the new pathway. “We also want stakeholder feedback on whether certain insulin products… raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products,” according to Dr Gottlieb’s statement released by the FDA. In addition, patients are being encouraged to provide input about experiences with insulin products to help inform the FDA in shaping the new approval pathway.
“American patients who rely on insulin to live deserve to have high-quality, affordable options,” wrote the Commissioner. “The FDA is dedicated to facilitating access to insulin. We hope our industry partners will join us in doing all we can to help people who need access to the live saving medicines, now.”
US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access [press release]. April 2, 2019. Accessed April 2, 2019.