抗ウイルス薬としてのバイオシミラー：感染症の脅威に対する迅速かつ費用対効果の高い展開に向けた科学的および規制上の準備状況

Rapid and equitable access to antiviral biologics in outbreaks is constrained by bespoke manufacturing, lengthy trials, and uneven procurement. Biosimilar antivirals could change responsiveness from single-source supply to multi-manufacturer preparedness if regulatory and chemistry, manufacturing, and controls (CMC) platforms are leveraged.

Evidence on antiviral biologic classes, orthogonal analytics, critical quality attributes, pharmacokinetic/pharmacodynamic (PK/PD) biomarkers, regulatory convergence, value assessment, and manufacturing scale-up is summarized. Platform CMC and tech-transfer enablers (e.g. single-use, modular/distributed facilities) are described alongside integration of dynamic transmission models with distributional cost-effectiveness analysis to address equity. The review evaluates how high-resolution analytical similarity, combined with comparative clinical pharmacology, can reduce the need for comparative clinical efficacy studies in selected programs. paradigm. Databases and regulatory/health technology assessment portals were searched from January 2010 to 10 October 2025. Predetermined criteria with structured extraction and consensus resolution were utilized for dual screening.

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.