Technical considerations on the study and evaluation of the biosimilars' immunogenicity
- Author:
Hai-Xue WANG
1
Author Information
- Publication Type:Journal Article
- Keywords: Anti-drug antibody; Biosimilar; Immunogenicity; Preclinical study, clinical study
- From: Chinese Pharmaceutical Journal 2015;50(6):483-489
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To evaluate the immunogenicity of biosimilars. METHODS: Non-clinical and clinical studies carried out in accordance with the guidelines in immunological characteristics and immunogenicity of biosimilars should focus on the production of anti-drug antibodies and detection of drug-resistant properties, immune complexes and their potential effects on pharmacodynamics/pharmacokinetics. Assays for immunogenicity of biological agents mainly include enzyme linked immunosorbent assay (ELISA), radioimmunoassay, surface plasm on resonance method, enzyme linked immunospot assay, immuno-PCR method, cell proliferation assay, etc. RESULTS AND CONCLUSION: Biosimilars immunogenicity should be comprehensively interpreted based on both the preclinical/clinical evaluation results and the prevalence of clinical adverse events.
