Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically.

Rodrigo BorregaJoao Paulo CruzPeter TaylorJoao Goncalves

Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2020)

Based on these results, an unsystematic assessment does not yield enough reporting across products and thus immunogenicity-related information should be reported in a systematic way. Further guidance about reporting immunogenicity-related information is required, otherwise SmPCs will not be the basis of information for healthcare professionals on how to use a biological product safely and effectively.

Keyphrases

health information
electronic health record
big data
adverse drug
machine learning