Organon Backs FDA Biosim Label Change

Organon says it agrees with a proposal in an FDA 9/18 draft guidance on biosimilar labeling that both biosimilars and interchangeables include a biosimilar statement.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, 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.”