Booth Jennifer Philippon, Pilz Jeffrey
The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Hosp Pharm. 2022 Aug;57(4):455-461. doi: 10.1177/00185787211046865. Epub 2021 Sep 16.
Due to the abbreviated approval pathway and extrapolation to non-studied indications, an increased importance is placed on post-marketing surveillance of biosimilars to supplement existing evidence and enhance patient and provider confidence. Bevacizumab-awwb (ABP 215, Mvasi) was the first biosimilar approved to bevacizumab (Avastin), a recombinant humanized monoclonal IgG1 antibody that inhibits the vascular endothelial growth factor (VEGF). To evaluate utilization, safety, and financial outcomes of bevacizumab-awwb compared to bevacizumab at a national cancer institute (NCI)-designated cancer center. A single center, retrospective, 1:1 indication-matched cohort study of adult patients who received bevacizumab or bevacizumab-awwb between October 1, 2019 and October 1, 2020 was performed. Thirty-four patients received bevacizumab-awwb during the study period and were matched by indication to 34 randomly selected patients who received bevacizumab. Indications for both groups included: colorectal cancer (n = 19), gynecologic cancer (n = 10), glioblastoma (n = 3), hepatocellular carcinoma (n = 1), and lung cancer (n = 1). Baseline and medication utilization characteristics were similar for this indication-matched cohort of 68 patients receiving bevacizumab-awwb or bevacizumab. Patients in the bevacizumab group had a higher proportion of public payer coverage (64.7% vs 38.2%, = .029). A higher proportion of patients in the bevacizumab-awwb group remained on active treatment at the end of the study period (52.9%) as compared to the bevacizumab group (35.3%); however, differences in final treatment status and reasons for discontinuation were not statistically significant ( = .218). Rates of worsened hypertension (44.1% vs 44.1%) and worsened proteinuria (38.2% vs 23.5%, = .077) were common in both groups. Grade 3 adverse drug events in the bevacizumab group included: gastrointestinal perforation (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 2), and venous thromboembolism (n = 2). Grade 3 adverse drug events in the bevacizumab-awwb group included: epistaxis (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 1), intracerebral hemorrhage (n = 1), venous thromboembolism (n = 3), and arterial thromboembolism (n = 1). One patient in the bevacizumab-awwb group experienced grade 4 hypertension. Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states.
由于生物类似药的审批途径缩短以及对未研究适应症的外推，加强生物类似药的上市后监测以补充现有证据并增强患者和医疗服务提供者的信心变得愈发重要。贝伐单抗-awwb（ABP 215，Mvasi）是首个获批的贝伐单抗（安维汀）生物类似药，贝伐单抗是一种重组人源化单克隆IgG1抗体，可抑制血管内皮生长因子（VEGF）。为了评估在一家国立癌症研究所（NCI）指定的癌症中心，与贝伐单抗相比，贝伐单抗-awwb的使用情况、安全性和财务结果。对2019年10月1日至2020年10月1日期间接受贝伐单抗或贝伐单抗-awwb的成年患者进行了一项单中心、回顾性、1:1适应症匹配队列研究。在研究期间，34例患者接受了贝伐单抗-awwb，并按适应症与34例随机选择的接受贝伐单抗的患者进行匹配。两组的适应症包括：结直肠癌（n = 19）、妇科癌症（n = 10）、胶质母细胞瘤（n = 3）、肝细胞癌（n = 1）和肺癌（n = 1）。对于这68例接受贝伐单抗-awwb或贝伐单抗的适应症匹配队列患者，基线和用药特征相似。贝伐单抗组公共支付者覆盖比例更高（64.7%对38.2%，P = 0.029）。与贝伐单抗组（35.3%）相比，贝伐单抗-awwb组在研究期末仍接受积极治疗的患者比例更高（52.9%）；然而，最终治疗状态和停药原因的差异无统计学意义（P = 0.218）。两组中高血压加重（44.1%对44.1%）和蛋白尿加重（38.2%对23.5%，P = 0.077）的发生率都很常见。贝伐单抗组3级药物不良事件包括：胃肠道穿孔（n = 1）、胃肠道出血（n = 1）、高血压（n = 2）和静脉血栓栓塞（n = 2）。贝伐单抗-awwb组3级药物不良事件包括：鼻出血（n = 1）、胃肠道出血（n = 1）、高血压（n = 1）、脑出血（n = 1）、静脉血栓栓塞（n = 3）和动脉血栓栓塞（n = 1）。贝伐单抗-awwb组有1例患者发生4级高血压。贝伐单抗-awwb每剂和每毫克的药物中位成本低于贝伐单抗，分别有15.8%和12.1%的折扣。在广泛的疾病状态下，这68例接受贝伐单抗或贝伐单抗-awwb的适应症匹配队列患者的使用情况和安全性结果相似。
