Biosimilars and Future Biotherapeutics

Immunogenicity Assessment and Risk Management

Immunogenicity Assessment and Risk Management” will explore one of the most critical aspects of biosimilar and biotherapeutic development—evaluating and managing immune responses to biologic products. Immunogenicity refers to the ability of a therapeutic protein to provoke an immune response in the body, which can potentially alter the drug’s efficacy, cause adverse events, or lead to treatment failure. Given the complex structure and manufacturing processes of biologics, even minor variations in formulation, storage, or handling can influence immunogenic potential. Therefore, accurate assessment and effective risk mitigation are essential components of the regulatory and clinical development pathway for biosimilars and next-generation biotherapeutics. bioanalytical strategy design, assay validation, and standardization methods used to compare immunogenic profiles between biosimilars and their reference products. Special emphasis will be placed on interpreting immunogenicity data in both preclinical and clinical settings, and understanding its impact on pharmacokinetics, safety, and therapeutic effectiveness. Regulatory guidance provided by agencies such as the FDA, EMA, and WHO on immunogenicity evaluation during product development and post-marketing surveillance. Experts will discuss risk management strategies,