Industry at Odds Over Biosimilar Interchangeability Labeling

Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance.

Interchangeability and biosimilarity statements would clarify differences and are supported by prescribers, Amgen said. “Knowledge of the biosimilarity or interchangeability status of a product is equally important … to make appropriate biologic substitution decisions,” Amgen said.

Amgen’s comments were consistent with those of Sanofi, Janssen and Abbvie, PhRMA and BIO. The comment period on the FDA’s draft guidance on biosimilar labels closed this week.