Proactive Safety Monitoring of Biosimilars: A Comprehensive Approach Combining Immunogenicity, Big Data, and Global Standards.

Authors

Megha Naudiyal, Arzoo Pannu, Shivang Gangotri, Utkarsh Kumar, Sunny Kumar Rao

Published in

Reviews on recent clinical trials. Sep 18, 2026. Epub Sep 18, 2026.

Abstract

The introduction of biosimilars into the marketplace has allowed more patients access to biological drugs through the development of alternative, but highly similar biological products. However, the complex nature of biosimilars in terms of structure, manufacture, and risk of immunogenicity requires strong and continual pharmacovigilance throughout the lifecycle of these biological products. The present review seeks to offer a comprehensive insight into existing pharmacovigilance practices for biosimilars, with a particular focus on immunogenicity, post-market surveillance, real-world evidence, digital technology, traceability, and regulatory practices. A narrative review was performed on relevant literature identified from PubMed, Scopus, Web of Science, and Google Scholar, alongside guidance and regulation on biosimilar pharmacovigilance from relevant regulatory agencies. This review indicates that successful pharmacovigilance for biosimilars necessitates the use of an approach that combines spontaneous adverse event reporting, active post-market surveillance, immunogenicity evaluation, real-world evidence, risk management, and product traceability. Novel strategies using artificial intelligence, machine learning, digital health tools, blockchain technology for traceability, and pharmacoepidemiology could enhance signal detection, better understand product identification, conduct long-term safety evaluations, and implement risk management. There still exist several challenges connected with data quality, interoperability, confidentiality, infrastructure, harmonization of regulations, and standardized approaches to biosimilar safety monitoring. Thus, an active, lifecycle-based pharmacovigilance system that integrates immunogenicity surveillance, real-world evidence, digital technologies, and standardized regulation is essential for improved biosimilar pharmacovigilance and clinical use of biosimilars.

PMID:
42770446
Bibliographic data and abstract were imported from PubMed on 22 Sep 2026.

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