The Federal Trade Commission is backing a recent FDA proposal to officially remove the requirement that biosimilar developers must run switching studies to obtain interchangeability designations.
Interchangeability allows pharmacists to substitute a brand-name biologic for a competing biosimilar without a doctor intervening.
The FDA currently recommends that biosimilar applicants run clinical switching studies to demonstrate that the biosimilar can be interchangeable with the reference biologic, but the agency announced in June that it wants to ease the process of obtaining the designation to make the market for biologics more competitive.
“Clinical switching studies can be time-consuming and expensive, and in the draft guidance the FDA has concluded that they are no longer recommended for applications seeking an interchangeable designation,” the FTC said Tuesday in a comment. “If implemented, this draft guidance would likely have a positive impact on the number of biosimilars designated as interchangeable and the uptake of biosimilar products in general by reducing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.”
The FTC also said it agrees with the FDA that the removal of the study requirement for interchangeable biosimilars will “dispel the false impression of separate safety and efficacy standards” for interchangeables and biosimilars.
The American Medical Association backed the FDA’s recommendation, highlighting last week how removing the requirement could improve access and lower costs.
“The proposed guidance will increase the number of biosimilars available for pharmacy-level substitutions, which should lead to increased patient access and reduced cost,” AMA CEO James Madara wrote.
He noted that the AMA rescinded its support for the interchangeability pathway at the annual meeting of the AMA’s House of Delegates in June.
The health system Kaiser Permanente also said it supports the FDA draft guidance and said last week that the “appreciable evidence supporting the safety and efficacy of biosimilars obviates the need for a separate interchangeability designation.”