Masterarbeit

A Comparative Analysis of Biosimilars Requirements in the EU, the US, and China: Commonalities, Differences, Case Studies and the Global Development Strategy

Yaofang Li (2025)

Summary:

The biosimilar industry seeks to develop unified global development programs to meet regulatory requirements across major markets, improving efficiency and patient access to affordable biologics. However, persistent regional regulatory differences create development challenges. Kirchlechner & Cohen's 2025 review identified both shared principles and significant variations in global biosimilar regulations that can delay approvals and increase costs. This paper focuses on the three most influential markets (EU, US, and China), analyzing their regulatory evolution over two decades and emerging trends. Following a comparative analysis of six key regulatory aspects, the study presents two case studies of Asian companies' registration strategies in these markets. These examples demonstrate evolving commercial approaches and regulatory developments, leading to proposed improvements for more efficient global biosimilar approval processes. The findings emphasize the need for greater regulatory harmonization to reduce barriers and accelerate patient access worldwide.

Pages: 58

Annexes: 2, Pages: 4