OBJECTIVES: A biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from an existing approved reference biological product. Once a biologic has lost exclusivity, biosimilars may enter the market, providing more cost-saving options for patients and healthcare systems in general. The aim of this study was to assess the current regulatory environment for biosimilars in the US and EU and the market hurdles in pre-launch, launch and post-launch stages and provide recommendations as to how China could potentially avoid similar inefficiencies in developing a regulatory framework for biosimilars.

METHODS: Qualitative research with key opinion leaders (KOLs) and regulators in US, EU and China was performed to understand the regulatory environment in those markets.

RESULTS: Our research identified insightful nuances and variations of interest across the US and EU5, which can be used to formulate a successful China-specific strategy for biosimilar adoption. We have provided a list of specific recommendations to policy makers, biosimilar manufacturers and payers that pull best practices from other major markets, while attempting to avoid potential distraction and delays.

CONCLUSIONS: The global biosimilar market has immense untapped potential. More fundamentally, in any local market, biosimilars are often more cost-effective options for patients and governments. As a result, the major players in China’s healthcare system should examine the lessons from the US and EU and develop a framework that aims to expand biosimilar development and improve access to affordable biologics.