Biological response modifiers monoclonal antibodies

The most promising types of biologic response modifiers are monoclonal antibodies, cytokines, and fusion proteins.1 Monoclonal antibodies may be chimeric (fused mouse and human segments designated -ximab ), humanized with intermittent murine sequences (designated -zumab ), human backbone with monkey sequences, or fully human.40... 

The biological activities of the product are influencing the immune response. An immune stimulating therapeutic protein is more likely to induce antibodies than an immune suppressive protein. Monoclonal antibodies targeted to cell bound epitopes are more likely to induce an immune response than monoclonal antibodies with a target in solution [20], Also the Fc bound activities of monoclonal antibodies have an influence. A monoclonal antibody with a modified Fc part has been reported to be less immunogenic than the unmodified monoclonal antibody [21],... 

The rituximab presentation to the Biologies Response Modifiers Advisory Committee (BRMAC) of the FDA took place on July 25, 1997 and the final approval was granted on November 26,1997 (Fig. 4) [55-58]. The EMEA granted approvi to rituximab in Europe in June 1998. Rituximab became the first monoclonal antibody approved for the treatment of cancer and specifically for patients with NHL. 

Dillman RO. Toxicities and side effects associated with intravenous infusions of murine monoclonal antibodies. Journal of Biological Response Modifiers 1986 5 73-84. 

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