On 20 August 2024, the FTC and US Biosimilars Council lent their support to the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines.
In draft guidance published by the FDA in June 2024, entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, the FDA has suggested removing its prior recommendation that a biosimilar applicant must submit clinical switching studies to demonstrate that a biosimilar is interchangeable with the reference drug. Instead, a biosimilar applicant may submit a statement to the FDA explaining why existing data in a BLA supports a designation of interchangeability.
In its comment to the FDA, the FTC provided its view that, if implemented, “the guidance would likely reduce barriers to entry and facilitate competition among biologic products by increasing the number of biosimilars designated as interchangeable”. The Biosimilars Council agreed with the FDA that “experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product”.
After considering comments received on the draft guidance (by 20 August 2024), the FDA intends to revise the final guidance for industry.