Regulatory Position

The FDA considers immunogenicity an important issue related to biotechnology products. The agency is particularly interested in the effects of antibody formation on the pharmacokinetic/pharmacodynamic properties of the protein. Based on these data, the immune response would be classified as neutralizing or nonneutralizing. In addition, the incidence or seventy of disease, new toxic effects, or other adverse effects should be considered in the data analyses prior to submission to the agency.

In some cases, the production of antibodies may not be biologically relevant. When there is no dose-response relationship and the antibodies are not neutralizing, there may be no safety related issues. It is, however, necessary to exclude the possibility of immune complex vasculitis as a potential health-related effect. Specialized histopathological techniques can be used to identify immune complexes in the kidney or vasculature.

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