OBJECTIVES: Between 2011 and 2015, 32 biologics valued at more than $55 billion are expected to lose patent protection across the world (Datamonitor 2011). The biologics patent cliff has presented a huge opportunity for biosimilar manufacturers. In the context of this growing biosimilars market, this research aimed to investigate the regulatory environments and the evidence (clinical, economic and humanistic) requirements to support reimbursement and prescription of biosimilar drugs in three Asian markets (Japan, South Korea and China).  METHODS: We conducted secondary research to review the macroeconomic factors impacting biosimilar entry (regulatory policy, intellectual property protection etc.) Payer/ physician guidance and positions on biosimilar use across markets and diseases were also reviewed. Following this, primary research was conducted with a mix of payers and physician stakeholders to understand:

• The therapy areas that payers/physicians consider most attractive for biosimilars;
• Payer/physician value drivers and evidence requirements (bioequivalence, comparative data etc.) across therapy areas that would support public reimbursement and prescription   
• Expectations around price differentials vs. branded biologics and the implications these differentials have on access and utilization of biosimilars 

RESULTS: Evidence requirements vary by market, with Japan and S.Korea being fairly consistent while China having lower thresholds. Evidence requirements also tend to vary by therapy area and complexity of the biologic. Overall, efficacy/ safety data and price are key value drivers for biosimilar reimbursement and uptake. In the absence of comparative data vs. the branded biologic, concerns around safety/efficacy may impact uptake but the promise of significant budget savings supports positive reimbursement/ access decisions.   CONCLUSIONS: The access environments for biosimilars in the developed markets of Japan and S.Korea can be expected to be similar to other developed markets across the world. However, China is likely to be more favourable than the developed markets when it comes to access and uptake of biosimilars.