Abstract

A RESEARCH ON REGULATORY PATHWAYS FOR BIOSIMILAR PRODUCT REGISTRATION FOR UNITED STATES, COLOMBIA, AND THE PHILIPPINES

*Ms. Sonali Rajendra Shejole, Dr. Lokesh Premchand Kothari

Abstract

Biosimilars have emerged as an essential component of modern healthcare systems by improving patient access to high-cost biological therapies while maintaining standards of quality, safety, and efficacy. Due to the inherent complexity of biological products, biosimilars require distinct regulatory pathways that differ significantly from those applied to conventional small-molecule generics. Regulatory frameworks governing biosimilar products vary across countries, reflecting differences in legal structures, regulatory maturity, and public health priorities. This review provides a comprehensive and comparative analysis of biosimilar product registration pathways in the United States, Colombia, and the Philippines. These jurisdictions were selected to represent a highly regulated market, a Latin American regulatory system with defined biosimilar legislation, and a Southeast Asian regulatory system incorporating reliance and regional harmonization approaches. The review examines key regulatory elements including legal frameworks, regulatory authorities, biosimilar approval pathways, dossier structure and submission requirements, reference product acceptability, and post-approval obligations. Special emphasis is placed on the role of the Common Technical Document–based dossier architecture and the practical reuse of core quality documents such as specifications and Certificates of Analysis across multiple jurisdictions. The analysis highlights both convergence and divergence in regulatory expectations, with all three systems adopting a comparability-based, stepwise evaluation approach while differing in procedural implementation and reliance mechanisms. The findings of this review aim to support regulatory professionals, researchers, and pharmaceutical manufacturers in developing efficient biosimilar registration strategies and in understanding evolving global trends in biosimilar regulation.

Keywords: Biosimilars, Biologics, Regulatory pathways, Biosimilar registration, CTD dossier, United States, Colombia, Philippines.