Anh-Duy Hoang Nguyen1,
Thu-Thao Thi Huynh2,
Minh Trong Quang1 
For correspondence:- Minh Quang Email: qtminh@ump.edu.vn
Received: 21 May 2026 Accepted: 19 October 2026 Published: 31 October 2026
Citation: Nguyen AH, Huynh TT, Quang MT. An overview of scientific principles, regulatory progress, and clinical integration of biosimilars in modern healthcare. Trop J Pharm Res 2026; 25(10):1465-1477 doi: 10.4314/tjpr.v25i10.14
© 2026 The authors.
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Biosimilars are therapeutic alternative options to originator biologics and can help address challenges to healthcare accessibility and sustainability. However, several scientific, regulatory, and practical issues stand in the way of their implementation, which need a thorough review. This review comprises an analysis of evidence available to date on the development, regulation, and clinical implementation of biosimilars, based on analyzing regulatory databases, peer-reviewed papers, and official guidance from the main regulatory agencies. The process of developing biosimilars requires a systematic and rigorous demonstration of similarity by analytical, non-clinical, and clinical studies. Regulatory systems have undergone dramatic change, and 144 biosimilars had been authorized in the European Union and 75 licensed in the United States by January 2025. Economic analyses suggest that biosimilar competition can reduce healthcare expenditure in Europe and the United States. However, there are implementation challenges arising from knowledge gaps between healthcare providers, patient concerns, and the need for regulatory harmonization. The immunogenicity profiles of biosimilars remain comparable to those of the reference products, supporting the principle of extrapolating indications based on the totality of the evidence. Biosimilars have proven to be safe and effective alternatives to reference products, but they must be implemented successfully, which requires continued education for stakeholders, regulatory harmonization, and evidence-based approaches. Advancements in analytical technologies and the science of regulation will further strengthen biosimilar development and help maintain high-quality standards, as established to be important to patient safety and therapeutic effectiveness.
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