On August 20, 2024, the Federal Trade Commission (FTC) released a comment expressing strong support for the U.S. Federal Drug Administration’s (FDA) efforts to streamline the approval process for interchangeable biosimilars.
The FTC’s support for the FDA’s draft guidance, which was unveiled in June 2024, is based on the belief that it will increase competition among biologic products, reduce barriers to entry, and ultimately lower healthcare costs for patients.
One of the key changes proposed by the FDA is the removal of the requirement for biosimilar drug applicants to submit clinical switching studies to demonstrate interchangeability. Instead, biosimilar applicants can now provide supporting rationale supplemented with existing data from the biologic license application.1
According to the FTC, this increased flexibility in the approval process will not only cut down the time and costs needed to demonstrate interchangeability but also help clear up lingering confusion about the safety and efficacy of biosimilars—an issue that has hindered their broader acceptance and use.2
Once the FDA designates a biosimilar as interchangeable, pharmacists can substitute the biosimilar for a brand-name biologic without the prescriber’s approval, following state laws.
“The draft FDA guidance is a step in the right direction to fully realizing the goals of the Biologics Price Competition and Innovation Act of 2009 (BPCIA),” said the FTC in a news release. “By increasing competition and innovation among biologics, which could lead to lower prices and increased choice for patients who depend on these life-saving medicines.”
The FTC emphasized the need to address anticompetitive practices that pose a barrier to the adoption of biosimilars. Contract terms that discourage generic drug insurance reimbursement, as revealed in the Commission’s Interim Staff Report on Pharmacy Benefit Managers, undermine the goals of the BPCIA to increase competition and innovation among biologics.3
The FTC also pointed out that, as of July 1, the FDA has approved 56 biosimilar products, but only 13 have been designated as interchangeable. The agency urged the FDA to offer additional guidance on how existing non-interchangeable biosimilars can apply for interchangeable status under the proposed streamlined process.
According to the FTC, “Applying the draft guidance to all biosimilars, including already-approved products that treat conditions affecting large patient populations…would support increased access to biosimilars and facilitate patient choice among safe and effective treatments.
By supporting the FDA’s draft guidance, the FTC appears to be taking a proactive stance to ensure that patients have access to affordable and effective biosimilar medications. The agency believes that this will lead to improved health outcomes and reduced healthcare costs for individuals and the broader healthcare system.
References
- U.S. Department of Health and Human Services, Food and Drug Administration. Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry. June 2024. Available at: https://www.fda.gov/media/179456/download
- The United States Federal Trade Commission. FDA Draft Guidance Biosimilar Drugs Comment Letter. August 20, 2024. Available at: https://www.ftc.gov/legal-library/browse/cases-proceedings/public-statements/fda-draft-guidance-biosimilar-drugs-comment-letter
- U.S. Federal Trade Commission, Office of Policy Planning. Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. July 2024. Available at: https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf