Details

Autor(en) / Beteiligte

• Guinn, Daphne
• Madabushi, Rajanikanth
• Wang, Yow‐Ming
• Zineh, Issam
• Maxfield, Kimberly

Titel

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

Ist Teil von

• Clinical pharmacology and therapeutics, 2021-03, Vol.109 (3), p.697-704

Ort / Verlag

United States

Erscheinungsjahr

2021

Quelle

Wiley-Blackwell Full Collection

Beschreibungen/Notizen

• 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.