POST-MARKETING PHARMACOVIGILANCE OF BIOSIMILARS: CONCEPTS, CHALLENGES, AND REGULATORY APPROACHES

Abstract

Biosimilars are biological medicinal products developed to be highly similar to licensed reference biologics in terms of quality, safety, and efficacy. Although rigorous comparability exercises are conducted before approval, the inherent complexity of biosimilars and their potential for immunogenicity necessitate robust post-marketing pharmacovigilance. This review highlights the key concepts, challenges, and regulatory approaches associated with post-marketing pharmacovigilance of biosimilars. It discusses the limitations of pre-approval clinical studies, the importance of real-world safety monitoring, and the need for effective traceability and adverse event reporting systems. Regulatory frameworks adopted by major authorities, including the European Union and the United States, are examined. The review also addresses challenges such as product switching, under-reporting, and manufacturing variability, and outlines strategies to strengthen pharmacovigilance systems to ensure patient safety and sustain confidence in biosimilar therapies.