Löfgren Hans
School of International and Political Studies, Deakin University, Melbourne, Australia.
Aust New Zealand Health Policy. 2007 Jun 1;4:10. doi: 10.1186/1743-8462-4-10.
This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.
本文概述了全球生物制药行业的新动态。具备与“大型制药公司”相当能力的全球仿制药公司的出现，加速了创新药和仿制药领域之间界限的模糊。基于生物技术的产品在处方药市场中占据了很大且不断增长的份额，生物仿制药的监管途径即将出台。拥有大规模高效生产工厂且研发能力不断增强的印度生物制药跨国公司，如今已成为发达国家和发展中国家活性药物成分（API）和仿制药的主要供应商。为应对仿制药竞争，创新药公司采用了一系列生命周期管理技术，包括推出“授权仿制药”。澳大利亚的仿制药市场在未来几年将实现高速增长，但当地制造业的前景不容乐观。国际市场上廉价仿制药的供应给药品福利计划（PBS）的定价安排带来了压力，2006年11月宣布了一项新的政策方向。仿制药价格降低将对一些现有供应商产生负面影响，但澳大利亚医药行业的产业振兴政策应更好地聚焦于高价值研发活动和复杂产品的利基制造。
