Immunogenicity of single administration therapeutic biologics for acute indication

• Authors: Park, Bomina, FDA/CDER (Student); Wang, Yow-Ming, FDA/CDER; Maxfield, Kimberly, FDA/CDER (Mentor)

• Center: Center for Drug Evaluation and Research

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Abstract

Immunogenicity of the therapeutic biologics and their related proteins can affect their pharmacological properties and may induce adverse immunologically related clinical events. There are numerous patient- and product-specific factors that may affect immunogenicity risk of therapeutic biologics. Of product-specific factors, dose and frequency of drug administration can affect the risk of immunogenicity and related immune response. In general, a frequent or chronic dosage regimens are considered to have a higher immunogenicity risk than a single dose regimen because multiple/ chronic administration of biologics allows for the ‘prime and boost’ phenomenon often utilized in vaccine development. However, FDA has never conducted a systematic review of the immunogenicity risk of single dose products that are not vaccines. Here, we aim to review existing immunogenicity data and identify potential factors that may contribute to immunogenicity risk of single administered biologics approved by the FDA. The list of FDA-approved therapeutic biologics, as of June 2021, were obtained from the Purple Book. A list of BLAs indicated for a single administration (N= 13 products) were identified. The product labeling and approval packages were reviewed to collect information on key immunogenicity risk and clinical assessment parameters and other product and patient related factors.

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