2026.09.08

Comparison of Biosimilar Development Guidelines: Japan, EU, and United States
Overview This document provides a comparative analysis of biosimilar regulatory guidelines across Japan (PMDA/ […]
2026.06.08

Considerations for Determining the Need for Comparative Efficacy Studies in Biosimilar Development in Japan
Introduction to PMDA’s Early Consideration on Comparative Efficacy Studies for Biosimilars According to the Ea […]