Published Paper Details:

Pharmacovigilance is essential for ensuring the safe use of biologics and biosimilars--medicines made from living systems that are often large and complex in structure. These products can have unique safety concerns such as immune reactions, changes between batches, and risks that may only appear after they are widely used. Monitoring methods like spontaneous reporting, active surveillance, and strong product tracking help detect and manage these issues. Regulatory bodies such as EMA, USFDA, and CDSCO require regular safety reports, risk management plans, and registry-based studies to improve safety tracking. However, challenges remain in tracing batches, interpreting data, and handling product switches. New tools like blockchain for traceability, advanced data analysis, and global safety standards are shaping the next phase of pharmacovigilance. This review discusses the importance of strong monitoring systems to keep biologics and biosimilars safe while supporting their wider use.