中国生物工程杂志

Antibodies trigger unwanted immune response, which influence the efficacy and safety of drugs. Therefore, it is necessary to evaluate immunogenicity of antibodies in different stage of development, including post-marketing surveillance. Immunogenicity evaluation is the key step in the development of all antibodies. The regulatory authorities have strict requirements on the immunogenicity of antibodies products for evaluation, there is a lack of uniform standards for the type, quantity, and quality of evidence,but also the lack of immunogenicity of antibodies guidance documents or immunogenic experimental design standards. New technologies promote the development of immunogenicity evaluation, the detection rate of immunogenicity also rise,therefore “head to head” clinical trials to evaluate the immunogenicity of antibodies. Therefore, the regulators and clinicians need to be aware of the change of immunogenicity analysis. Here, the related factors of immunogenicity of antibodies, potential clinical consequences, changes of the current regulatory guidance and development of non clinical and clinical studies of immunogenicity evaluation methods were discussed. And a special note of immunogenicity evaluation on biosimilars was also discussed.