US FDA proposes to remove switching study requirement for biosimilars

By Thomson Reuters Jun 20, 2024 | 11:06 AM

(Reuters) – The U.S. Food and Drug Administration has proposed that biosimilar drugs seeking agency’s interchangeable designation will no longer need studies showing the impact of switching between them and the branded drug.


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

AbbVie’s top-selling arthritis drug Humira has held onto its share of more than 80% of patients even after facing competition from nine lower-priced biosimilar rivals in the U.S. in the last year.

That has raised questions about whether the market for prescription biosimilars can survive in its current form, drug pricing experts and analysts have said.

Regulatory reform is needed so patients can more easily access biosimilars and draw rival drugmakers to develop them.


The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar.

But recent studies showed no differences in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and those who did not.

The agency said analytical tools available today can accurately evaluate the structure and effects of biologic products with more precision than switching studies.

The agency will seek comments from the industry before finalizing the proposed guidance.


Out of the 13 approved interchangeable biosimilars in the past, nine were approved without additional switching study data, the FDA said.


“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.

(Reporting by Mariam Sunny and Bhanvi Satija in Bengaluru; Editing by Anil D’Silva)