Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Länsisatamankatu 24 A 5, 00220, Helsinki, Finland.
HUS Pharmacy, HUS Helsinki University Hospital, Helsinki, Finland.
BioDrugs. 2022 Jul;36(4):537-547. doi: 10.1007/s40259-022-00540-y. Epub 2022 Jul 6.
Biological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases. Biosimilars, clinically equivalent to biological originator products, are expected to restrain drug costs in the biological market.
This study aimed to examine the impact of the biosimilar market entry on the prices of the reference products in outpatient care in Finland, investigate the impact of biosimilar market entries on price competition among biological medicinal products, and examine how the prices and market shares of outpatient biosimilars have developed in Finland during 2009-2020.
This retrospective register study applied data from IQVIA covering national community pharmacy wholesale data between 1 January, 2009, and 31 August, 2020, for somatropin, epoetin, filgrastim, follitropin, insulin glargine, insulin lispro, etanercept, pegfilgrastim, adalimumab, teriparatide, and enoxaparin biosimilars and their reference products, in addition to two relevant insulin products. We determined the monthly wholesale amounts in defined daily doses and wholesale weighted average prices (excluding value-added tax) per defined daily dose for each product. We analyzed the evolution of the price and market shares. We performed a linear segmented regression analysis to examine the impact of the market entry of biosimilars on the prices of reference products.
The prices of the reference products mainly decreased after the biosimilar entered the market. If the reference product price was not reduced, it was no longer reimbursable after evaluation under the Health Insurance Act, leading to marginal market shares. The changes in the prices of biosimilars were not as remarkable as the changes in the prices of reference products after the biosimilar market entry. For most active substances, biosimilar prices were stable or decreased. The utilization of biosimilars varied widely between different active substances at the end of the observation period.
Changes in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future.
生物制药通常价格昂贵，在药品成本中所占份额不断增长。然而，它们在治疗许多慢性病方面至关重要。生物类似药与生物原创产品在临床上等效，有望控制生物市场的药品成本。
本研究旨在考察生物类似药进入市场对芬兰门诊护理中参比产品价格的影响，研究生物类似药进入市场对生物药品之间价格竞争的影响，并考察 2009-2020 年期间芬兰门诊生物类似药的价格和市场份额如何发展。
本回顾性登记研究应用 IQVIA 提供的数据，涵盖 2009 年 1 月 1 日至 2020 年 8 月 31 日期间全国社区药房批发数据，涉及生长激素、促红细胞生成素、非格司亭、卵泡刺激素、甘精胰岛素、赖脯胰岛素、依那西普、聚乙二醇化非格司亭、阿达木单抗、特立帕肽和依诺肝素生物类似药及其参比产品，以及两种相关胰岛素产品。我们确定了每个产品的每月批发数量和每定义日剂量的批发加权平均价格（不含增值税）。我们分析了价格和市场份额的演变。我们进行了线性分段回归分析，以考察生物类似药进入市场对参比产品价格的影响。
参比产品的价格主要在生物类似药进入市场后下降。如果参比产品价格没有降低，根据《健康保险法》进行评估后，它将不再报销，导致市场份额边缘化。生物类似药价格的变化不如生物类似药进入市场后参比产品价格的变化显著。对于大多数活性物质，生物类似药价格保持稳定或下降。在观察期末，不同活性物质的生物类似药利用率差异很大。
与生物类似药进入市场相关的定价政策和公共报销计划的变化是参比产品价格下降的主要原因。因此，生物类似药并没有在生物产品之间产生真正的价格竞争。在检查的许多药物组中，生物类似药的市场份额在未来具有增长潜力。
