由于医疗花费大幅增长以及应对COVID19疫情的支出，需要药物递送解决方案，以便于在肿瘤学高剂量单克隆抗体（mAbs）的灵活护理环境下使用。这份专家意见介绍了一种基于类比的框架，用于指导mAb药物的相关产品改进决策，这些药物已经获得授权或处于后期临床开发阶段。此框架的四个支柱包括（1）市场上现有和新兴治疗方法的药物递送情况，（2）接受mAbs治疗者的需求和偏好，（3）现有的医疗基础设施，以及（4）有国家相关的报销和采购模式。以下是基于该领域的原始研究和审查文章评估的mAb治疗的产品优化示例：皮下制剂，是一种已建立的药物递送模式，可减少注射剂量的复杂性，固定剂量组合，是一个新兴的概念，可作为联合治疗的补充，以及（连接的）贴身递送系统，是一种确定的未来机会，可支持在受控医疗机构环境之外使用药物。利用已有的疾病领域的协同作用和经验教训，可以降低相关的开发和商业化成本，从而在药物的初始上市时提供可持续的产品。

The substantial acceleration in healthcare spending together with the expenditures to manage the COVID19 pandemic demand drug delivery solutions that enable a flexible care setting for high-dose monoclonal antibodies (mAbs) in oncology.This expert opinion introduces an analogue-based framework applied to guide decision-making for associated product improvements for mAb medications that are either already authorized or in late-stage clinical development. The four pillars of this framework comprise (1) the drug delivery profile of current and emerging treatments in the market, (2) the needs and preferences of people treated with mAbs, (3) existing healthcare infrastructures, and (4) country-dependent reimbursement and procurement models. The following product optimization examples for mAb-based treatments are evaluated based on original research and review articles in the field: subcutaneous formulations, an established drug delivery modality to reduce parenteral dosing complexity, fixed-dose combinations, an emerging concept to complement combination therapy, and (connected) on-body delivery systems, an identified future opportunity to support dosing outside of a controlled healthcare institutional environment.Leveraging existing synergies and learnings from other disease areas is a measure to reduce associated development and commercialization costs and thus to provide sustainable product offerings already at the initial launch of a medication.