National Health Insurance Research Institute, National Health Insurance Service, 32 Geongang-ro, Wonju, South Korea.
College of Pharmacy, Woosuk University, 443 Samnye-ro, Wanju-gun, South Korea.
Appl Health Econ Health Policy. 2020 Aug;18(4):557-566. doi: 10.1007/s40258-019-00547-7.
South Korea is unique in that it leads global markets in R&D as well as production of biosimilar products and was the first market into which some biosimilar products were introduced. We analyzed the time trend of market penetration and simulated saved spending by biosimilars in South Korea.
We pulled Korean National Health Insurance claims data from January 2012-December 2018 for second-generation biologics, including infliximab, rituximab, and trastuzumab, and examined the time trends of expenditure, utilization in defined daily dose, and price. We also assessed market penetration by biosimilars and simulated expenditure savings gained due to their introduction. We comparatively examined time trends and spending savings during the same period for selected small-molecule generic drugs to understand any specifics limited to biosimilars for time trends of market share and quantity-standardized prices.
The market share for infliximab biosimilar plateaued at over 30%, which is smaller than the market penetration of esomeprazole (over 60%), a small-molecule comparator. Despite a shorter observation period, rituximab and trastuzumab biosimilars also showed larger utilization rates (12.89% and 13.93%, respectively) than infliximab (9.05%) in their second year after market entry. Infliximab was associated with approximately US $82-114 million expenditure savings over 6 years after its biosimilar entry to the market. Rituximab and trastuzumab biosimilars each also resulted in reduction in total spending by approximately US $9-14 million, in less than 2 years.
Biosimilars captured the market rapidly, despite a heterogeneous uptake rate by product in South Korea. However, expansion of biosimilar use in the market and consequent expenditure savings need to be supported by pre-emptive policy measures to encourage price competition and boost utilization.
韩国在研发和生物类似药生产方面引领全球市场,并且是最早引入部分生物类似药的市场之一。我们分析了韩国市场生物类似药的市场渗透时间趋势,并对其节省的支出进行了模拟。
我们从 2012 年 1 月至 2018 年 12 月提取了韩国国家健康保险索赔数据,用于第二代生物制剂,包括英夫利昔单抗、利妥昔单抗和曲妥珠单抗,并考察了支出、按日剂量定义的利用情况和价格的时间趋势。我们还评估了生物类似药的市场渗透情况,并模拟了因引入生物类似药而节省的支出。为了了解生物类似药市场份额和数量标准化价格的时间趋势方面的任何特殊情况,我们还比较了同期选定的小分子仿制药的时间趋势和节省的支出。
英夫利昔单抗生物类似药的市场份额稳定在 30%以上,低于小分子对照药埃索美拉唑(超过 60%)的市场渗透水平。尽管观察期较短,但利妥昔单抗和曲妥珠单抗生物类似药在进入市场后的第二年的利用率也高于英夫利昔单抗(分别为 12.89%和 13.93%)。英夫利昔单抗生物类似药进入市场后 6 年内,可节省约 8200 万至 1.14 亿美元的支出。利妥昔单抗和曲妥珠单抗生物类似药在不到 2 年内,也分别减少了约 900 万至 1400 万美元的总支出。
尽管韩国产品的采用率存在差异,但生物类似药迅速占领了市场。然而,需要采取先发制人的政策措施来支持生物类似药在市场上的使用和相应的支出节省,以鼓励价格竞争和提高利用率。