ASCO Comments on Interchangeability of Biosimilars


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ASCO submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s proposed guidance for industry on demonstrating the interchangeability of biosimilars with a reference product. The Society reiterated its strongly held position that physicians and patients should have the ability to select evidence-based treatment options—including the specific biologic product—most appropriate for a patients’ circumstance.

ASCO largely agreed with the FDA’s proposed approach, and the Society’s comments focused on three key areas:

  • Totality of Evidence: ASCO indicated its support for the FDA’s totality of evidence approach but urged the agency to clearly outline the data and information needed to support a demonstration of interchangeability.
  • Switching, Alternating, and Substituting: ASCO advised the FDA to clarify the evidence needed to demonstrate interchangeability through the definition and expectations of the proposed switching and alternating studies. 
  • Postmarketing Safety Monitoring: ASCO applauded the FDA for including postmarketing safety monitoring considerations. As more biosimilars enter the market, meaningful postmarketing surveillance is key to identifying rare or delayed—but potentially serious—safety risks. ■

© 2017. American Society of Clinical Oncology. All rights reserved.



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