Immunogenicity Risk Assessment Explained: Ultimate Guide to Biosimilar and Biologics Safety Mastering Immunogenicity Risk Assessment: Compliance-Ready Guide for Biologics and Biosimilars Introduction to Immunogenicity Risk Assessment and Its Importance Immunogenicity risk assessment evaluates the potential of biologics and biosimilars to trigger unwanted immune responses in patients. Regulatory agencies including the FDA, EMA, and CDSCO require sponsors to conduct thorough immunogenicity assessments throughout development and post-approval phases. These assessments are vital as immune reactions can lead to reduced efficacy, safety concerns, or even life-threatening events. By 2025, immunogenicity has emerged as a critical regulatory focus for biosimilars and advanced biologics. With…