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Immunogenicity Rates: Peptides vs Biologics Comparison
Antidrug antibodies can develop over time and reduce efficacy or cause adverse immune reactions. Taspoglutide development halted during Phase III trials after ADA formation occurred in 49% of subjects, with 31 of 51 patients withdrawing due to allergic or anap
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- Antidrug antibodies can develop over time and reduce efficacy or cause adverse immune reactions. Taspoglutide development halted during Phase III trials after ADA formation occurred in 49% of subjects, with 31 of 51 patients withdrawing due to allergic or anaphylactoid reactions. FDA guidelines require immunogenicity risk assessment for impurities above 0.1%.