[Regulatory consequences for the use of monoclonal antibodies]

Köhler and Milstein published a method for the manufacture of mouse monoclonal antibodies of predefined specificity 1975 [1], a work rewarded with the Nobel Prize 1984. Since then, the field has developed rapidly with new production methods such as recombinant DNA technology, phage display and genetically engineered animals. Following the first clinical applications with a mouse monoclonal antibody, new classes as chimaeric, humanized and human monoclonal antibodies appeared, with the advantages of less adverse reactions and better efficacy. The development over more than 30 years resulted in more than 25 approved products on the market for various therapeutic applications, e.g. for the treatment of cancer, inflammatory diseases, heart disease and transplantation, and medicines for many more applications are currently under development.