WASHINGTON — The Biosimilars Council commented this week on the FDA’s June 2024 Draft Guidance Docket No. FDA–2017-D-0154, focused on considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. The Biosimilar Council appreciates and agrees with the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines.
“An interchangeable designation has no bearing on the safety, effectiveness or quality of a biosimilar,” said Craig Burton, Executive Director for the Biosimilars Council. “We agree with the draft guidance which states, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant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.”
In 2023, savings from the use of biosimilar medicines increased by more than 30 percent, to $12.4 billion. Since their introduction in 2014, biosimilars have generated $36 billion in savings. Biosimilars continue to demonstrate their safety and effectiveness—with more than 2.7 billion days of patient therapy with no meaningful differences in clinical outcomes.
The June 2024 Draft Guidance is consistent with, and further supported by, the FDA’s position in the April 2024 draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. Taken together, the FDA’s June 2024 and April 2024 Draft Guidance are an important step towards facilitating the approval and acceptance of interchangeable biosimilar products, which can increase patient access to critical therapies and decrease healthcare costs.
