生技仿製藥規範與公費報銷政策對藥廠經營策略之影響 — 美國、歐洲與日本制度之比較分析

Abstract

This thesis identifies major trends in biosimilar regulations and reimbursement policies, using the US, EU, and Japan pharmaceutical markets as the case subjects. Research is focused on a comparative analysis of regulatory policies with respect to market licensing of biosimilars and major reimbursement policies affecting market use of biosimilars. The information from this comparative analysis, as well as data reported by biologic manufacturers, is used to evaluate the corporate strategies that incumbent, patent holding biologic manufacturers are pursuing to respond to future biosimilar competition. Lastly, recommendations are provided to domestic biosimilar manufacturers planning to enter their home market of Taiwan. Regulatory agencies in the US, EU, and Japan have established abbreviated review processes to allow biosimilars to come to market faster than if they were to be reviewed as completely new molecular entities. Key differences between the agencies are in granting ‘interchangeable/substitutable’ labels and in the timing of the first biosimilar submission. For instance, the US FDA’s option for biosimilars to be licensed as ‘interchangeable,’ a shorter time in which biosimlars have to wait to submit applications, and an exclusivity period for the first-to-market biosimilar will theoretically encourage wider biosimilar adoption in the market. The US is expected to have wide variation in biosimilar reimbursement policies as policies will vary on the size of the insurance market and the level of competition between plan administrators. On the other hand, the EU member states analysed for reimbursement policies - Germany, France, and the UK - and Japan have national-level policies that influence the type of pharmaceuticals covered as benefits and their reimbursement prices. European countries were found to use pricing tools, such as negotiated discounts, reference pricing, and tendering, that should provide an opportunity for biosimilars to gain market share. Differences in major regulations and reimbursement policies in the studied markets were found to lead to differences in the degree of potential competition between biologics and biosimilars. In response to greater potential biosimilar competition in the US, biologics marketed for the US were more likely to take legal action to defend patent rights. In Japan, the market determined to have the lowest degree of potential biosimilar competition, the incumbent biologic manufacturers were more likely to apply for additional indications, which can be revenue increasing only without biosimilar competition. Lastly, the EU, which is the more mature system in terms of regulation and reimbursement policies for dealing with biosimilars, also sees incumbents applying for new indications, as well as developing new biologics to cannibalise sales of the existing biologic. Finally, advice for Taiwan domestic biosimilar manufacturers are to work with the government in developing regulations and health insurance policies more favorable for biosimilars, and to gain first-mover advantage as preferred suppliers for large hospitals and medical centers, focussing on additional incentives manufacturers can offer providers for biosimilars requiring infusions.