We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . . made to licensed biosimilars and licensed interchangeable biosimilars.”
Last week, the FTC published a comment supporting the FDA’s draft guidance, stating an interest in the draft guidance because “[c]ompetition brings substantial benefits to consumers through lower prices, greater access to higher quality goods and services, and increased innovation.” The FTC highlighted that the draft guidance no longer recommends clinical switching studies for applications seeking an interchangeable designation, commenting that clinical switching studies can be “time-consuming and expensive” and that “relying on clinical switching studies to establish interchangeability has likely contributed to marketplace confusion about biosimilars . . . for patients and providers about whether biosimilars are as safe and effective as other biologic products.” The FDA draft guidance also explains that it would be false or misleading to suggest that a reference product is safer or more effective than a biosimilar product or that different pathways to FDA approval impact the relative safety and effectiveness of the products. This is important, the FTC notes, because both the FDA and the FTC have previously expressed serious concerns about false or misleading statements disparaging biosimilars and their safety and efficacy because they “can increase provider and patient mistrust of and confusion about biosimilar and interchangeable products.” The FTC concludes that “[i]f implemented, this Draft Guidance would likely have a positive impact on the number of biosimilars designated as interchangeable and the uptake of biosimilar products in general by reducing barriers to entry and increasing competition in biologic marketplaces . . . [which] is a step in the right direction to fully realizing the goals of the BPCIA to increase competition and innovation among biologics, [and] could lead to lower prices and increased choice for consumers who depend on these life-saving medicines.”
To the extent this guidance is implemented, the FTC urges the FDA to provide further guidance on how already-approved non-interchangeable biosimilars may request an interchangeable designation because, as FTC notes, there is currently “no guidance for how an already-approved biosimilar may request an interchangeable designation under the simplified process. Applying the draft guidance to all biosimilars, including already-approved products that treat conditions affecting large patient populations, such as insulins and Humira biosimilars, would support increased access to biosimilars and facilitate patient choice among safe and effective treatments.” And finally, “to ensure Americans receive the benefits of the increased access to interchangeable biosimilars” the FTC proposes that “agencies must continue to be attentive to the risk that anticompetitive practices, if left unchecked, could foreclose or forestall such access.”
The draft guidance remains open for public comment until September 23, 2024.