On March 9, 2020, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) held a workshop entitled “FDA/FTC Workshop on Competitive Marketplace for Biosimilars.” The agencies announced that the purpose of the workshop was to “discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace.”
On April 9, 2020, Aimed Alliance submitted a comment to the agencies in response to the workshop. Aimed Alliance noted its support for the development of and improved access to biosimilars because they increase patients’ treatment options and have the potential to provide cost savings through competition. It also highlighted the need for efforts to improve the adoption of biosimilars by limiting sham citizen petitions. However, it cautioned against the use of nonmedical switching, noting that stable patients should be permitted to stay on their current medication, regardless of whether their medication is biologic or a biosimilar, unless the prescriber determines otherwise. Aimed Alliance also recommended that the agencies use their enforcement authority against any entity that makes false or misleading statements about biosimilars, but also cautioned against the limiting of truthful statements. Read our comment here.