Biosimilars as antivirals: scientific and regulatory readiness for rapid, cost-effective deployment in infectious threats

The field is moving toward PK/PD-anchored, analytics-first pathways that, with thorough mapping of structure - function relationships, may limit the need for Phase III trials. Pre-specified PD/analytic packages are provided for each modality/virus, along with reference product batch libraries, bridging plans, reliance agreements, and standing commission regulations to operationalize this approach in an emergency.