FDA Plans to Ease Requirements for Biosimilars’ Interchangeable Status

The FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded reference product does not present any potential safety risks or risk of diminished efficacy.

In new draft guidance, the agency is suggesting a “revised approach where such studies will generally not be needed.”

Any physician can prescribe a biosimilar in place of a branded reference product, but the interchangeable status brings the advantage of being able to be substituted without need for a prescription change at the pharmacy level in some states, similar to generic drugs.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars, said in a statement.

“We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the last 10 years. 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,” added Yim.

The agency has approved 13 interchangeable biosimilars — including products biosimilar to adalimumab (Humira), insulin glargine (Lantus), ranibizumab (Lucentis), ustekinumab (Stelara), and denosumab (Prolia, Xgeva), among others. While the agency recommended switching studies to support the interchangeable status in its 2019 guidance, only four of the products were actually approved with the support of one of these studies.

FDA said the change comes after considerable experience with biosimilars since its 2019 guidance.

“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,” the agency stated.

In a systematic review and meta-analysis, for example, researchers found “no differences in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.”

The agency also stated that today’s analytical tools can evaluate biologics with greater precision and sensitivity than switching studies.

FDA is seeking comment from stakeholders on its proposed guidance.