a Clinical Epidemiology unit, Department of Medicine Solna , Karolinska Institutet , Stockholm , Sweden.
b Department of Rheumatology , Karolinska University Hospital , Stockholm , Sweden.
Expert Opin Biol Ther. 2018 May;18(5):499-504. doi: 10.1080/14712598.2018.1458089. Epub 2018 Apr 10.
To describe the uptake and system-level effects of the introduction of biosimilars in a setting without forced switching.
We used data from the Swedish Rheumatology Quality register from start of marketing of infliximab (Remsima® and Inflectra®) and etanercept (Benepali®) biosimilars until 31 December 2016. We compared users of each originator-product and its biosimilar(s) by line of treatment: bDMARD-naïve patients, non-medical switchers (vs. matched patients remaining on originator), and patients switching from a previous bDMARD of another type.
From the start of marketing 1343 patients started an infliximab biosimilar (22 months) and 2691 started etanercept (9 months). Overall, the introduction of these biosimilars resulted in an increase of the total number of ongoing infliximab and etanercept treatments (originator + biosimilar) . At the end of the study period, biosimilars accounted for 31% of all infliximab treatments and 31% of all etanercept-treated patients. For each line of therapy, we noted only small differences in patient characteristics between those starting the originator product vs. its biosimilar(s).
Introduction of biosimilars have effects beyond replacement of the originator product, in terms of an increased rate of bDMARD initiation. Selection to non-medical switching displayed no particular disease- or patient-characteristics.
在没有强制转换的情况下，描述生物类似药引入后的采用情况和系统层面的影响。
我们使用了从开始销售英夫利昔单抗（Remsima®和 Inflectra®）和依那西普（Benepali®）生物类似药到 2016 年 12 月 31 日的瑞典风湿病质量登记处的数据。我们通过治疗线比较了每种原研产品及其生物类似药的使用者：bDMARD 初治患者、非医疗转换者（与继续使用原研药的匹配患者相比）和从另一种类型的先前 bDMARD 转换的患者。
从开始销售以来，有 1343 名患者开始使用英夫利昔单抗生物类似药（22 个月），2691 名患者开始使用依那西普生物类似药（9 个月）。总体而言，这些生物类似药的引入导致正在进行的英夫利昔单抗和依那西普治疗总数增加（原研药+生物类似药）。在研究期末，生物类似药占所有英夫利昔单抗治疗的 31%和所有依那西普治疗患者的 31%。对于每种治疗线，我们注意到开始使用原研产品与生物类似药的患者在患者特征方面仅有很小的差异。
生物类似药的引入除了替代原研产品之外，还会增加 bDMARD 的起始率。非医疗转换的选择没有表现出特定的疾病或患者特征。
