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- Title
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
- Authors
Guinn, Daphne; Madabushi, Rajanikanth; Wang, Yow‐Ming; Zineh, Issam; Maxfield, Kimberly
- Abstract
Insufficient availability of data to evaluate immunogenicity incidence or clinical impact during regulatory review could require further evaluation postapproval. Through a keyword search of all postmarketing requirements and commitments (PMRs/PMCs) associated with products with their original US Food and Drug Administration (FDA) approvals between 2009 and 2018, we identified products that had PMRs/PMCs established to address concerns or uncertainty related to immunogenicity. Of the 113 relevant products, 50% had an immunogenicity‐related PMR/PMC; of these, 68% were related to developing immunogenicity assays and 48% requested an assessment of clinical impact. Fifty‐five percent of the products with a fulfilled PMR/PMC had a change in the immunogenicity information in their labeling immediately following fulfillment. This work highlights that there are often unknowns associated with immunogenicity incidence and/or impact at the time of approval. Earlier regulatory discussions on immunogenicity assessments in premarket development could improve the understanding and communication of the risk/benefit profile and reduce the need for some immunogenicity PMRs/PMCs.
- Subjects
KEYWORD searching; TECHNICAL specifications; DRUG labeling; RISK communication
- Publication
Clinical Pharmacology & Therapeutics, 2021, Vol 109, Issue 3, p697
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.2038