The U.S. Food and Drug Administration has proposed changes that would exempt biosimilar drugs seeking the agency's interchangeable designation from needing studies demonstrating the impact of switching between them and the branded drug.

Importance of the Designation

This designation allows pharmacists to substitute branded drugs with their close copies easily.

AbbVie's top-selling arthritis drug, Humira, has maintained over 80% market share among patients despite facing competition from 9 lower-priced biosimilar rivals in the U.S. over the past year. This situation has raised concerns about the viability of the current prescription biosimilars market, according to drug pricing experts and analysts.

Experts argue that regulatory reform is necessary to facilitate patient access to biosimilars and incentivize drugmakers to develop them.

Context

Traditionally, the FDA has recommended conducting switching studies to demonstrate a biosimilar's interchangeability. However, recent research indicated no significant differences in the risk of death, serious adverse events, or treatment discontinuations between participants who switched between biosimilars and those who did not. The FDA stated that modern analytical tools can now accurately assess the structure and effects of biologic products, rendering switching studies less critical.

The FDA intends to solicit feedback from the industry before finalizing the proposed guidance.

By the Numbers

Out of the 13 approved interchangeable biosimilars to date, 9 were approved without additional switching study data, the FDA reported.

"Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product," said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA.