Public Hearing to Address Insulin Prices, Biosimilar Insulins

The FDA is hosting a public hearing to discuss access to affordable insulin products, and the regulatory issues related to the development and evaluation of biosimilar and interchangeable insulin products.^1-2 The hearing will take place May 13, 2019 at the agency’s headquarters in Silver Spring, Maryland.¹

According to the agency, access to insulin can be increasingly difficult for some individuals to obtain as list prices regularly increase by double digits. These increases have raised serious concerns about the ability for many patients in need of insulin for diabetes management and survival to access this medication. This week, a House of Representatives subcommittee heard from stakeholders affected by the rising costs of insulin, and with the hearing, the Agency intends to "inform steps the FDA can take to advance access to insulin products, including biosimilar and interchangeable insulin products,” said FDA Commissioner Scott Gottlieb, MD, in a prepared statement.²

According to Gottlieb, the FDA is working to expand access to biologics, and insulins could be regulated as biologics in 2020. Once insulins are regulated as biologics, it will be possible for developers to seek interchangeable designations for their subsequent-entry versions, which will allow for pharmacy-level substitution and the potential for cost savings.²

“Until recently, biologics lacked effective competition because there was no abbreviated pathway for bringing follow-on versions of biologics to market under the PHS Act, similar to the generic pathway we have for small molecule drugs under created under the 1984 Hatch Waxman amendments to the FD&C Act. In 2010, Congress, through the Biologics Price Competition and Innovation Act (BPCI Act), gave the FDA the authority to implement a pathway for approval of biosimilar and interchangeable products, to open biologics to competition, ultimately providing more treatment options, increasing access to lifesaving medications and potentially lowering health care costs,” said Gottlieb.² “This transition is particularly important for insulin.”

Officials with the FDA are anticipating biosimilar and interchangeable insulin products will deliver competition needed to help bring affordable treatment options to patients.² Those cost savings are desperately needed by patients with diabetes, where 1 in 4 patients ration their medication due to price, according to testimony this week told the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.

To participate in or attend the public hearing, visit the FDA's published notice.¹

References

• The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Public Hearing; Request for Comments. Federal Register. https://www.federalregister.gov/documents/2019/04/03/2019-06438/the-future-of-insulin-biosimilars-increasing-access-and-facilitating-the-efficient-development-of. Published April 3, 2019. Accessed April 3, 2019.
• Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access [news release]. Silver Spring, MD; April 2, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634999.htm. Accessed April 3, 2019.