Technical considerations on the study and evaluation of the biosimilars' immunogenicity / 中国药学杂志
Chinese Pharmaceutical Journal
; (24): 483-489, 2015.
Article
in Zh
| WPRIM
| ID: wpr-859415
Responsible library:
WPRO
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.
Full text:
1
Index:
WPRIM
Type of study:
Guideline
Language:
Zh
Journal:
Chinese Pharmaceutical Journal
Year:
2015
Type:
Article