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.
