Biosimilars and Future Biotherapeutics

Pharmacovigilance and Post-Marketing Surveillance

Pharmacovigilance and Post-Marketing Surveillance will delve into the critical role of long-term safety monitoring in the lifecycle management of biosimilars and other biotherapeutic products. While pre-approval clinical trials provide essential data on the safety, efficacy, and quality of biosimilars, they are often conducted on limited populations over defined periods. Therefore, once a biosimilar enters the market and is exposed to broader, more diverse patient populations under real-world conditions, robust pharmacovigilance systems become essential to continuously monitor and assess product performance, detect rare or unexpected adverse effects, and maintain patient safety.Biologics, including biosimilars, have unique characteristics—such as structural complexity and sensitivity to manufacturing processes—that make them more prone to variability than traditional small-molecule drugs. This variability can influence immunogenicity, therapeutic response, and long-term safety. In this context, the importance of post-marketing surveillance (PMS). Key components of pharmacovigilance—such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), signal detection, benefit-risk assessment, and product traceability. European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Health Canada, and World Health Organization (WHO) enforce post-approval monitoring through structured reporting mechanisms and mandatory safety programs.