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The challenge of integrating monoclonal antibodies into the current healthcare system.

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.