Car Elif, Vulto Arnold G, Houdenhoven Mark Van, Huys Isabelle, Simoens Steven
Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
Hospital Pharmacy, Erasmus University Medical Centre, Rotterdam, Netherlands.
Front Pharmacol. 2023 Apr 21;14:1151764. doi: 10.3389/fphar.2023.1151764. eCollection 2023.
Factors like the number of biosimilar competitors and competitive pricing strategies from originator companies may influence price competition and biosimilar uptake. The aim of this study was to analyze multiple facets of biosimilar competition of TNF-alpha inhibitors in Europe by exploring the existence of a biosimilar first-mover advantage, pricing strategies of originator companies, and the evolution in patient access. Sales and volume data on biosimilar and originator infliximab, etanercept, and adalimumab between 2008 and 2020 were provided by IQVIA. Countries included 24 European Union Member States, Norway, Switzerland, United Kingdom, Serbia, and Bosnia and Herzegovina. Sales value was expressed as ex-manufacturer price per defined daily dose (DDD), and volume data were transformed into the number of DDDs per 1,000 inhabitants per day. Descriptive analyses were conducted based on the evolution in price per DDD, trends in biosimilar and originator market shares and utilization trends. Market entry of the first biosimilars of infliximab and adalimumab resulted in a decrease of the volume-weighted average price (VWAP) per DDD by 13.6% and 0.9% on average, whilst the second biosimilars resulted in a decrease by 26.4% and 27.3%, respectively. The first and second etanercept biosimilars generated a similar decrease in the VWAP per DDD by 9.3% and 9.1% on average, respectively. Average market share captured by the first biosimilars was at least twice as large as the second biosimilars for all molecules. In addition, sharp reductions in price per DDD of Humira in most countries indicated a pricing strategy resulting in low uptake of adalimumab biosimilars. Lastly, utilization of infliximab, etanercept, and adalimumab following biosimilar entry increased by an average of 88.9%, 14.6%, and 22.4%, respectively. However, introduction of (multiple) biosimilar competitors did not necessarily translate into increase in treatment access for all three molecules across some European countries indicating a shift in utilization from one molecule towards the other(s). Overall, this study revealed that biosimilar entry results in increased utilization and price reduction, although at a heterogenous rate among TNF-alpha inhibitors. Observed trends in market shares indicate a biosimilar first-mover advantage whereas pricing strategies considered to be anti-competitive can limit market uptake.
生物类似药竞争对手的数量以及原研公司的竞争性定价策略等因素可能会影响价格竞争和生物类似药的采用情况。本研究的目的是通过探究生物类似药的先动优势、原研公司的定价策略以及患者可及性的演变，来分析欧洲肿瘤坏死因子-α抑制剂生物类似药竞争的多个方面。艾昆纬提供了2008年至2020年生物类似药和原研英夫利昔单抗、依那西普和阿达木单抗的销售及销量数据。所涉国家包括24个欧盟成员国、挪威、瑞士、英国、塞尔维亚和波斯尼亚和黑塞哥维那。销售价值以每限定日剂量（DDD）的出厂价表示，销量数据转换为每千居民每日的DDD数量。基于每DDD价格的演变、生物类似药和原研药市场份额趋势以及使用趋势进行了描述性分析。英夫利昔单抗和阿达木单抗首个生物类似药的上市分别使每DDD的加权平均价格（VWAP）平均下降了13.6%和0.9%，而第二个生物类似药则分别使价格下降了26.4%和27.3%。首个和第二个依那西普生物类似药使每DDD的VWAP平均下降幅度相近，分别为9.3%和9.1%。对于所有分子，首个生物类似药获得的平均市场份额至少是第二个生物类似药的两倍。此外，多数国家修美乐每DDD价格的大幅下降表明其定价策略导致阿达木单抗生物类似药的采用率较低。最后，生物类似药上市后，英夫利昔单抗、依那西普和阿达木单抗的使用量分别平均增加了88.9%、14.6%和22.4%。然而，在一些欧洲国家，（多个）生物类似药竞争对手的出现并不一定意味着这三种药物的治疗可及性都有所提高，这表明使用情况从一种药物转向了其他药物。总体而言，本研究表明，生物类似药的上市导致了使用量增加和价格降低，尽管肿瘤坏死因子-α抑制剂之间的变化速率存在差异。观察到的市场份额趋势表明生物类似药存在先动优势，而被认为具有反竞争性质的定价策略可能会限制市场采用。
