Journal of Pathology, Communicable Diseases and Preventive Medicines

Authors: Dr. Neha Sharma, Mr. Rahul Verma

ABSTRACT: Biologics and biosimilars have emerged as transformative therapeutic agents with high efficacy for chronic and complex diseases. Due to their structural complexity, immunogenicity, and potential for unexpected adverse drug reactions (ADRs), pharmacovigilance is critical for ensuring their safe use. This paper reviews current strategies in post-marketing surveillance of biologics and biosimilars, focusing on regulatory frameworks, reporting systems, and integration of real-world evidence. Tables summarize pharmacovigilance components, reporting methodologies, and global implementation examples. Challenges such as underreporting, immunogenicity monitoring, and data heterogeneity are discussed. Future directions include enhanced use of artificial intelligence for signal detection, harmonization of international safety standards, and capacity-building for healthcare professionals. The study emphasizes that robust pharmacovigilance practices are essential for patient safety and therapeutic effectiveness in biologics and biosimilars.

KEYWORDS: Pharmacovigilance, Biologics, Biosimilars, Adverse Drug Reactions, Risk Management, EMA, FDA, PvPI