The FDA on Thursday began easing the process for biosimilar developers to demonstrate interchangeability with their brand-name biologics.
The agency previously required studies to prove that switching between the biosimilar and the brand name did not cause any additional safety or efficacy issues. But now, the agency says companies can use analyses of comparative analytical and clinical data instead of switching studies to win the interchangeable tag.
That shift will save biosimilar developers millions of dollars in conducting the switching studies, with the FDA even explaining that biosimilar applications that are pending can be updated with the new analyses.
The FDA said in a statement that its researchers found no differences in the risk of death, serious adverse events and treatment discontinuations among participants who switched between biosimilars and brand-name products and participants who did not switch in a recently conducted systematic review and meta-analysis.
Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in an interview with Endpoints News in April that having two separate classes of biosimilars has been “confusing people for a long time.”
She noted that some people wrongly assumed differences in quality between biosimilars and interchangeable biosimilars, even when both are held to the FDA’s highest standard of approval.
Instead, Yim said the FDA wants to make all biosimilars interchangeable with a legislative proposal that would eliminate the statutory distinction between biosimilars and interchangeables.
But before that legislative proposal takes shape, this change in the draft guidance could help industry bring to market more interchangeables.
The move also follows consistent FDA flexibility around interchangeables dating back to at least 2022. The FDA granted approval to Coherus BioSciences’ anti-VEGF drug Cimerli, an interchangeable biosimilar to Roche’s injection Lucentis, without running switching studies and based on the strength of its analytical, clinical and manufacturing data.
More recently, Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz both won approval last month as interchangeable biosimilars to Regeneron’s blockbuster Eylea, and the FDA confirmed that switching studies were not run.
The updated draft guidance explains how moving forward, companies do not need to run switching studies if they can assess the risk, “in terms of safety and diminished efficacy, from alternating or switching between the reference product and the proposed interchangeable product is not greater than the risk of using the reference product without such alternation or switch.”