The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland,BioDrugs

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The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland
BioDrugs ( IF 5.4 ) Pub Date : 2022-07-06 , DOI: 10.1007/s40259-022-00540-y
Saana V Luukkanen ₁ , Hanna M Tolonen _{1,

2} , Marja Airaksinen ₁ , Laura S M Saarukka ₁

Affiliation

Background

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.

Objective

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.

Methods

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.

Results

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.

Conclusions

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.

中文翻译：

芬兰原始生物制剂及其生物仿制药的价格和市场份额演变

背景

生物药物通常很昂贵，并且在药物成本中所占的份额不断增加。然而，它们对于治疗许多慢性疾病至关重要。生物仿制药在临床上等同于生物原研产品，有望抑制生物市场的药物成本。

客观的

本研究旨在探讨生物类似药市场进入对芬兰门诊参考产品价格的影响，调查生物类似药市场进入对生物医药产品价格竞争的影响，以及门诊价格和市场份额如何变化。 2009-2020 年期间，芬兰开发了生物仿制药。

方法

这项回顾性登记研究应用了来自 IQVIA 的数据，涵盖 2009 年 1 月 1 日至 2020 年 8 月 31 日期间的全国社区药房批发数据，包括生长激素、依泊汀、非格司亭、促卵泡素、甘精胰岛素、赖脯胰岛素、依那西普、培非格司亭、阿达木单抗、特立帕肽和依诺肝素生物仿制药及其参考产品，以及两种相关的胰岛素产品。我们确定了每种产品的限定日剂量的每月批发量和每限定日剂量的批发加权平均价格（不包括增值税）。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，以检验生物仿制药进入市场对参考产品价格的影响。