Abstract

Pankaj Dubey, Somesh Saxena, Dr. Shailesh Jain, Dr. Rita Mourya

ABSTRACT

Biosimilar medications represent a rapidly growing segment of the pharmaceutical industry, offering potential cost savings and increased patient access to biologic therapies. This review examines the complex regulatory landscape governing biosimilar approval across major jurisdictions, including the United States, European Union, and other key markets. We analyze the scientific principles underlying biosimilar development, comparative analytical and clinical requirements, post-market surveillance obligations, and emerging regulatory trends. The regulatory framework for biosimilars differs significantly from generic small-molecule drugs due to the structural complexity of biologic products and their manufacturing processes. Understanding these requirements is essential for pharmaceutical companies, healthcare providers, and policymakers navigating this evolving therapeutic landscape.