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Biosimilar Surveillance

Meaning

Biosimilar Surveillance is the rigorous, ongoing post-market monitoring process implemented by regulatory agencies to track the safety and effectiveness of approved biosimilar medicinal products. This critical phase of pharmacovigilance ensures that biosimilars, which are highly similar but not identical copies of reference biologics, maintain their clinical performance and safety profile once widely used in the general patient population. Comprehensive surveillance includes collecting and analyzing adverse event reports and immunogenicity data to detect any clinically meaningful differences from the original biologic. This regulatory practice is essential for maintaining public confidence in the integrity of the pharmaceutical supply chain.