Bristol Haematology & Oncology Centre, Bristol, UK.
Target Oncol. 2012 Mar;7 Suppl 1(Suppl 1):S57-67. doi: 10.1007/s11523-011-0196-3. Epub 2012 Jan 17.
The main rationale for using biosimilar drugs is for cost saving. The market development for biosimilar drugs will therefore depend on the degree to which cost saving measures are required by nations, medical insurers and individuals and the absolute savings that could be gained by switching from original drugs. This paper is designed to discover the degree to which financial constraints will drive future health spending and to discover if legal or safety issues could impact on any trend. A structured literature search was performed for papers and documents to 27 August 2011. Where multiple sources of data were available on a topic, data from papers and reports by multinational or national bodies were used in preference to data from regions or individual hospitals. Almost all health systems face current significant cost pressures. The twin driver of increasing cancer prevalence as populations age and cancer medicine costs rising faster than inflation places oncology as the most significant single cost problem. For some countries, this is predicted to make medicine unaffordable within a decade. Most developed countries have planned to embrace biosimilar use as a cost-control measure. Biosimilar introduction into the EU has already forced prices down, both the price of biosimilar drugs and competitive price reductions in originator drugs. Compound annual growth rates of use have been predicted at 65.8% per year. Most developed countries have planned to embrace biosimilar use as a major cost-control measure. Only legal blocks and safety concerns are likely to act against this trend. For centralised healthcare systems, and those with a strong tradition of generic medicine use, biosimilar use will clearly rise with predictions of more than 80% of prescriptions of some biologic drugs within 1 year of market entry in the USA. Delaying the implementation of such programmes however risks a real crisis in healthcare delivery for many countries and hospitals that few can now afford.
使用生物仿制药的主要理由是为了节省成本。因此，生物仿制药的市场发展将取决于各国、医疗保险公司和个人对节省成本措施的需求程度，以及从原药转换可能获得的绝对节省。本文旨在发现财政限制将在多大程度上推动未来的医疗支出，并发现法律或安全问题是否会影响任何趋势。对截至 2011 年 8 月 27 日的论文和文件进行了结构化文献检索。如果一个主题有多个数据源，优先使用来自跨国或国家机构的论文和报告中的数据，而不是来自地区或个别医院的数据。几乎所有的卫生系统都面临着当前的巨大成本压力。随着人口老龄化，癌症发病率不断上升，以及癌症药物成本的增长速度超过通胀，癌症已经成为最大的单一成本问题。对于一些国家来说，预计在十年内，药品将变得无法负担。大多数发达国家都计划将生物仿制药的使用作为一种控制成本的措施。生物仿制药在欧盟的引入已经迫使价格下降，生物仿制药的价格和原研药的竞争降价都有所下降。预计使用的年复合增长率为 65.8%。大多数发达国家都计划将生物仿制药的使用作为一种主要的成本控制措施。只有法律障碍和安全问题可能会阻碍这一趋势。对于集中式医疗保健系统和那些具有使用仿制药传统的国家来说，生物仿制药的使用显然会随着预测而增加，在美国，一些生物药物的处方中有超过 80%将在市场进入后的 1 年内使用。然而，推迟实施这些计划可能会给许多国家和医院带来医疗服务提供的真正危机，因为现在很少有国家和医院能够负担得起。
