Brixner D I, Bull S A
Novartis Pharmaceutical, Summit, NJ 07901, USA.
Am J Manag Care. 1997 Jun;3(6):903-11.
Although there are few monoclonal antibody (MoAb) products on the market, the biotechnology industry has made considerable progress over the last decade. The industry has developed new technology to address the primary hurdles facing the development of MoAbs--including the immune response to murine-derived antibodies as well as lack of tumor specificity. As the techniques for development become more refined, more products will be approved by the Food and Drug Administration. Integrating these products into the existing healthcare system will be a challenge, given their high acquisition costs. Recent pharmacoeconomic examples outlined in this paper confirm that MoAb products will need to be supported with proven clinical and economic profiles. As long as a global clinical and economic perspective is taken and patient care benefits can be demonstrated, the place of MoAbs in the future of healthcare will be assured.
尽管市场上的单克隆抗体（MoAb）产品较少，但在过去十年中生物技术行业取得了长足进展。该行业已开发出新技术，以应对单克隆抗体开发面临的主要障碍，包括对鼠源抗体的免疫反应以及缺乏肿瘤特异性。随着开发技术日益精细，将有更多产品获得美国食品药品监督管理局的批准。鉴于其高昂的购置成本，将这些产品整合到现有的医疗体系中将是一项挑战。本文概述的近期药物经济学实例证实，单克隆抗体产品需要具备经过验证的临床和经济学特性作为支撑。只要从全球临床和经济学角度出发，并能证明对患者护理有益，单克隆抗体在未来医疗保健中的地位将得以确立。
