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# Organon Backs FDA Biosim Label Change
- URL: https://www.fdaweb.com/organon-backs-fda-biosim-label-change/
- Published: 2023-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:15:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155749

Organon says it agrees with a proposal in an FDA 9/18 draft guidance on biosimilar labeling that both biosimilars and interchangeables include a biosimilar statement. In a comment [letter](ttps://downloads.regulations.gov/FDA-2016-D-0643-0070/attachment%5F1.pdf), the company says it agrees with the agency’s rationale that the interchangeability standard is not likely to be useful to prescribers and thus can more appropriately be placed in the *Purple Book*.

“Organon believes that FDA’s robust biosimilar regulatory approval standard is sufficient to designate a biologic as both biosimilar and interchangeable through a designation,” the letter says. “The creation of this interchangeable designation has led to a barrier for biosimilar adoption in the U.S. by inadvertently suggesting that it denotes a higher quality standard than biosimilarity. The lack of an interchangeability designation has been cited as a reason some providers are reluctant to use non-interchangeable biosimilars, even in the physician-infused setting.”