Global Regulatory Harmonization for Biosimilars: Current Progress, Challenges, and Future Directions

Biosimilars have emerged as a cost-effective alternative to reference biologics, with the potential to enhance access to life-saving treatments and reduce healthcare costs. However, their regulatory approval processes differ significantly across countries, posing challenges in global development and commercialization. This study systematically reviews current biosimilar regulatory frameworks, focusing on efforts toward harmonization by organizations like the International Council for Harmonisation (ICH), World Health Organization (WHO), and key national agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and India's Central Drugs Standard Control Organization (CDSCO). A mixed-methods approach, combining a review of existing literature with an analysis of regulatory documents, was employed. Findings show alignment in scientific requirements such as analytical characterization and comparability studies, but notable differences remain in clinical data requirements, policies on interchangeability, and post-marketing surveillance. The study highlights scientific, legal, and policy challenges to harmonization and proposes strategic actions to enhance global regulatory alignment. Promoting international cooperation, harmonization could streamline biosimilar development, reduce duplication, and accelerate patient access to high-quality biologics worldwide.