US FDA approves Samsung Bioepis and Biogen’s Byooviz

美国FDA批准三星Bioepis和Biogen的Byooviz

2021-09-22 00:30:08 PHARMACEUTICAL

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The US Food and Drug Administration has approved Samsung Bioepis and Biogen’s Byooviz , a biosimilar referencing Lucentis . Byooviz is an anti-vascular endothelial growth factor (VEGF) treatment that can prevent the loss of eyesight in people suffering with retinal vascular disorders that can lead to irreversible blindness or visual impairments in adults. This is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). Developed by Samsung Bioepis, the drug is claimed to be the first ophthalmology biosimilar to receive approval in the US. It has already been approved in Europe, including 27 European Union (EU) member countries, and in the UK last month. The FDA approval is based on a totality of data that includes analytical, non-clinical and clinical data. In November last year, the FDA accepted the companies’ biologics licence application for SB11, a proposed biosimilar referencing Lucentis Biosimilars are biological products that are said to be similar in efficacy and safety to the originator’s reference product and provide cost savings and boost sustainable access to treatments. In November 2019, Samsung Bioepis and Biogen signed a commercialisation deal for two ophthalmology biosimilar candidates, SB11 and SB15, which a biosimilar candidate referencing EYLEA (aflibercept). The company said that Biogen will commercialise SB11 under the brand name Byooviz in the US. Samsung Bioepis senior vice-president and development division leader Kyung-Ah Kim said: “In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. “The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world.” Under the terms of a global license agreement with Genentech, the companies will have the right to market SB11 in the US as of June 2022 before the expiration of Genentech’s applicable SPCs. Samsung Bioepis and Biogen will also have right to market the drug elsewhere in other territories after the expiration of Genentech’s SPCs.
美国食品药品监督管理局已经批准了三星Bioepis和Biogen的Byooviz,这是一种参考Lucentis的生物类似物。 Byooviz是一种抗血管内皮生长因子(VEGF)治疗,可以防止患有视网膜血管疾病的人丧失视力,这些疾病可能导致成人不可逆转的失明或视力障碍。 它适用于新生血管性(湿性)老年性黄斑变性(AMD)、视网膜静脉阻塞后黄斑水肿(RVO)和近视脉络膜新生血管(mCNV)的治疗。 该药物由三星Bioepis开发,据称是第一个在美国获得批准的眼科生物类似物。 它已经在欧洲获得批准,包括27个欧盟成员国,上个月还在英国获得批准。 FDA的批准是基于包括分析数据、非临床数据和临床数据在内的全部数据。 去年11月,美国食品和药物管理局接受了两家公司对SB11的生物制品许可申请,这是一种参考Lucentis的拟议生物类似物 生物仿制药是一种生物制品,据说在功效和安全性上与发起人的参考产品相似,可以节省成本,促进可持续地获得治疗。 2019年11月,三星Bioepis和Biogen签署了两项眼科生物相似候选项目SB11和SB15,这是一项参考EYLEA(aflibercept)的生物相似候选项目的商业化协议。 该公司表示,Biogen将在美国以Byooviz品牌将SB11商业化。 三星Bioepis高级副总裁兼开发部门负责人Kyung-Ah Kim说:“在美国,大约有1100万人患有AMD,由于人口老龄化,晚期AMD的患病率正在上升。 “美国首个雷尼珠单抗生物类似物的批准对美国视网膜血管疾病患者来说是一个不朽的里程碑。 “Byooviz的批准强调了我们继续致力于为世界各地无法获得提高生命的生物药物的人提供有价值的治疗选择。” 根据与基因泰克的全球许可协议条款,两公司将有权在基因泰克适用的SPCs到期前,于2022年6月在美国销售SB11。 三星Bioepis和Biogen也将有权在基因泰克的SPCS到期后在其他地区销售该药物。

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