Biosimilars: FDA offers rationale for dropping interchangeability designations

A top biologics official with the US Food and Drug Administration (FDA) explained the agency’s rationale in proposing to eliminate interchangeability designations in prescriber labeling for biosimilars, including that prescribers often don’t pay attention to this information when evaluating biosimilars.

In a recent blog post, Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, elaborated on some of the points raised in the agency’s September 2023 draft guidance on biosimilar labeling, which recommended removing details about interchangeability from biosimilar drug labels (RELATED: Biosimilar labeling guidance suggests cutting interchangeability details from labels, Regulatory Focus 18 September 2023).

The prescribing information in the drug labeling is written for health care professionals whose sole purpose is to convey the “essential scientific information” needed for the safe and effective use of the product, Yim explained, while information about interchangeability is relevant to substitution at the pharmacy.

“We believe that statements in the Prescribing Information identifying that products have been approved as interchangeable with the reference product and describing the interchangeability standard are not necessary for informing the safe and effective use of the product to prescribing health care professionals,” Yim wrote in the blog post.

Yim said the information about which products are licensed as interchangeable can be found in FDA’s Purple Book: Database of Licensed Biological Products.

Yim also endorsed the guidance’s proposals to establish a single biosimilar application. “As we gain more experience with licensing biosimilar and interchangeable biosimilar products, we are finding that a single biosimilar application and associated Prescribing Information may include both biosimilar and interchangeable biosimilar products at the same time,” she wrote.

In the blog post, Yim also seeks to clear up a misperception that interchangeable products are somehow safer or more effective than biosimilars. She asserts that an interchangeability designation “does not indicate a higher level of biosimilarity.”
“Health care professionals can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products,” Yim wrote.

The proposed guidance will not affect pharmacy-level substitution of interchangeable biosimilar products, and not including an interchangeability statement in the product’s prescribing information “does not change the status of the product or mean that the product is not interchangeable,” she wrote.

Labeling blog post

Biosimilars: FDA offers rationale for dropping interchangeability designations

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