Background Although the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and market competitiveness in South Korea. Methods A list of originator drugs approved by the national authority from 2000 to 2019 and their corresponding generic drugs were grouped along with the baseline information. The market was categorized into four groups based on the number of manufacturers: duopoly (2 manufacturers); low- (3–25 manufacturers); medium- (26–75 manufacturers); and high-competition (more than 76 manufacturers) markets. Price variance, calculated as the difference between the maximum price and minimum price divided by the maximum price, was obtained. A multivariate regression model was applied to regress price variance on the characteristics of market competitiveness, controlling for the characteristics of the originator drugs and their price level in the market. Results A total of 986 originator drugs were identified and then divided into duopoly (31%), low- (56%), medium- (9%), and high-competition (4%) markets; the median of the price variance for these markets was 0.013, 0.077, 0.200, and 0.228, respectively. In a multivariate regression model, price variance was associated with the characteristics of the originator drug, including the Anatomical Therapeutic Chemical classification, the route of administration, and the approval year. Controlling for the characteristics of the originator drugs, market competitiveness was positively associated with price variance. Conclusions The positive association between price variance and market competitiveness is still consistent in South Korea, where rare price competition among a large number of generic manufacturers has been reported. However, no significant price variance was observed between medium- and high-competition markets. These findings support policies for managing a large number of generic manufacturers in South Korea.

中文翻译：

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更大的仿制药竞争是否也与韩国较低的药品价格有关？

背景技术尽管已在各种高收入国家中探索了仿制药价格与市场竞争力之间的关联，但韩国尚未对这种关联进行实证评估。我们旨在确定仿制药价格与韩国市场竞争力之间的关联。方法将2000年至2019年国家主管部门批准的原产药物清单及其相应的仿制药与基准信息进行分组。根据制造商的数量将市场分为四类：双头垄断（2家制造商）；低（3至25个制造商）；中（26-75个制造商）；和竞争激烈的（超过76个制造商）市场。价格差异，计算方式为最高价格与最低价格之间的差额除以最高价格，获得了。应用多元回归模型对市场竞争力特征上的价格差异进行回归，控制原始药品的特征及其在市场中的价格水平。结果共鉴定出986种原研药，然后将其划分为双头垄断（31％），低（56％），中（9％）和高竞争（4％）市场；这些市场的价格差异中位数分别为0.013、0.077、0.200和0.228。在多元回归模型中，价格差异与原始药物的特征相关，包括解剖学化学分类，给药途径和批准年份。控制原始药品的特性，市场竞争力与价格差异呈正相关。结论在韩国，价格差异和市场竞争力之间的正相关性仍然是一致的，据报道，在韩国大量仿制药生产商之间罕见的价格竞争。但是，在中，高竞争市场之间没有观察到明显的价格差异。这些发现为在韩国管理大量仿制药生产商提供了支持政策。