The FDA has approved the country’s first biosimilar for adults with cancer. Bevacizumab-awwb, which will be marketed as Mvasi, has been approved to treat the same types of cancers as its reference product, bevacizumab, which is sold as Avastin. The drug is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF). By blocking VEGF’s interaction with its receptors, bevacizumab-awwb prevents the development of new blood vessels that solid tumors need to thrive. Bevacizumab-awwb and bevacizumab are from different manufacturers that use their own unique cell line and proprietary processes. Differences between the 2 drugs aren’t clinically meaningful in terms of safety, purity, and potency. In a statement, FDA Commissioner Scott Gottlieb, MD, said new biosimilar development, especially for diseases with high-cost treatments, “is an important way to help spur competition that can lower health care costs and increase access to important therapies.” Bevacizumab-awwb was approved for administration with chemotherapy for certain patients with metastatic colon cancer, nonsquamous non–small cell lung cancer, and cervical cancer. The drug also is approved in combination with interferon alfa for patients with metastatic renal cell cancer and following prior therapy for patients with progressive glioblastoma. The FDA said its approval was based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that show bevacizumab-awwb is biosimilar to bevacizumab. Common adverse events include epistaxis, headache, hypertension, rhinitis, proteinuria, dry skin, rectal hemorrhage, taste alteration, lacrimation disorder, back pain, and skin irritation. The drug also can cause fistula formation, arterial and venous thromboembolic events, posterior reversible encephalopathy syndrome, and ovarian failure. In addition, bevacizumab-awwb carries a boxed warning alerting clinicians and patients to the increased risk of gastrointestinal perforation, surgery and woundhealing complications, and hemorrhage.

中文翻译：

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静脉注射淋巴瘤药物获批

FDA 已经批准了该国第一个用于成人癌症的生物仿制药。Bevacizumab-awwb 将作为 Mvasi 销售，已被批准用于治疗与其参考产品贝伐单抗相同类型的癌症，贝伐单抗作为阿瓦斯汀销售。该药物是一种重组免疫球蛋白 G1 单克隆抗体，可与血管内皮生长因子 (VEGF) 结合。通过阻断 VEGF 与其受体的相互作用，bevacizumab-awwb 可防止实体瘤生长所需的新血管的发育。Bevacizumab-awwb 和 bevacizumab 来自不同的制造商，它们使用自己独特的细胞系和专有工艺。这两种药物之间的差异在安全性、纯度和效力方面没有临床意义。在一份声明中，FDA 专员 Scott Gottlieb 医学博士说，新的生物仿制药开发，尤其是对于治疗成本高的疾病，“是帮助刺激竞争的重要方式，可以降低医疗保健成本并增加获得重要疗法的机会。” Bevacizumab-awwb 被批准用于某些转移性结肠癌、非鳞状非小细胞肺癌和宫颈癌患者的化疗。该药物还被批准与干扰素 α 联合用于转移性肾细胞癌患者和进行性胶质母细胞瘤患者的先前治疗。FDA 表示，其批准是基于对证据的审查，包括广泛的结构和功能特征、动物研究数据、人体药代动力学和药效学数据、临床免疫原性数据、以及其他显示贝伐单抗-awwb 与贝伐单抗生物类似的临床安全性和有效性数据。常见的不良事件包括鼻衄、头痛、高血压、鼻炎、蛋白尿、皮肤干燥、直肠出血、味觉改变、流泪障碍、背痛和皮肤刺激。该药物还可引起瘘管形成、动脉和静脉血栓栓塞事件、后部可逆性脑病综合征和卵巢功能衰竭。此外，bevacizumab-awwb 带有黑框警告，提醒临床医生和患者注意胃肠道穿孔、手术和伤口愈合并发症以及出血的风险增加。该药物还可引起瘘管形成、动脉和静脉血栓栓塞事件、后部可逆性脑病综合征和卵巢功能衰竭。此外，bevacizumab-awwb 带有黑框警告，提醒临床医生和患者注意胃肠道穿孔、手术和伤口愈合并发症以及出血的风险增加。该药物还可引起瘘管形成、动脉和静脉血栓栓塞事件、后部可逆性脑病综合征和卵巢功能衰竭。此外，bevacizumab-awwb 带有黑框警告，提醒临床医生和患者注意胃肠道穿孔、手术和伤口愈合并发症以及出血的风险增加。