ASCO Comments on Interchangeability of Biosimilars
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. ■
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