Key drivers for market penetration of biosimilars in Europe.
Key drivers for market penetration of biosimilars in Europe.
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DOI：
10.1080/20016689.2016.1272308
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Toumi M
中科院分区：
文献类型：
--
作者：
Rémuzat C;Dorey J;Cristeau O;Ionescu D;Radière G;Toumi M
背景与目的：主要通过定性方法分析生物类似药吸收的潜在驱动因素和障碍。本研究的目的是进行定量分析，并确定欧盟（EU）所有可用生物类似药的生物类似药吸收驱动因素。 研究方法：建立了一个三步流程，以确定前10个欧盟成员国（MS）药品市场采用生物仿制药的关键驱动因素（比利时、法国、德国、希腊、匈牙利、意大利、波兰、西班牙、瑞典和英国）：（1）文献综述，以确定促进生物类似药采用的激励政策;（2）基于数据库分析评估生物类似药市场动态;（3）使用以下解释变量对价格进行回归模型分析：激励政策;生物类似药与原研药之间的价格差异;分销渠道;仿制药使用和仿制药降价;人均药品费用;市场竞争。 结果：在研究截止日期，市场上有20种生物类似药。应用于生物仿制药的激励政策在各国之间存在差异，不同治疗类别和国家之间的生物仿制药吸收率也非常不均匀。该模型的结果表明，激励政策和首次进入生物类似药市场的日期与生物类似药的吸收相关。人均药品支出和最高仿制药摄入量与生物仿制药摄入量呈负相关。相对于原研药和生物仿制药数量的平均仿制药价格折扣显示出与生物仿制药吸收相关性的统计学显著性趋势，但未达到显著性阈值。生物仿制药价格折扣超过原始生物价格，类似物的数量和分销渠道与生物仿制药的吸收无关。 结论：了解生物类似药吸收的驱动因素成为告知政策决策者的关键问题。这项研究表明，促进吸收的激励政策仍然是生物类似药渗透的重要驱动力，而生物类似药价格折扣没有影响。当生物类似药市场成熟时，未来的研究是有必要的。
Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition. Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake. Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.