Advanz Pharma and Alvotech have announced that the European Commission (EC) has granted marketing authorization for Mynzepli (formerly AVT06), a biosimilar to aflibercept (Eylea; Bayer and Regeneron). The approval allows Mynzepli to be marketed across the European Union and several additional European countries for the treatment of multiple serious retinal diseases..

Advanz Pharma和Alvotech宣布，欧洲委员会（EC）已批准Mynzepli（前称AVT06）的上市许可，这是一种阿柏西普（Eylea；拜耳和再生元）的生物类似药。该批准允许Mynzepli在欧盟及多个其他欧洲国家上市销售，用于治疗多种严重视网膜疾病。

Indications and Formulation

适应症与配方

Mynzepli has been approved in a 40 mg/mL pre-filled syringe and vial formulation. It is indicated for the treatment of several adult retinal conditions, consistent with the reference product aflibercept. These include neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), visual impairment due to macular edema secondary to branch or central retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV)..

Mynzepli 已获批准以 40 mg/mL 预充式注射器和小瓶制剂上市。该药物适用于治疗多种成人视网膜疾病，与参比产品阿柏西普的适应症一致。这些疾病包括新生血管性（湿性）年龄相关性黄斑变性 (nAMD)、糖尿病性黄斑水肿 (DME)、因分支或中央视网膜静脉阻塞 (RVO) 引发的黄斑水肿导致的视力损害，以及近视性脉络膜新生血管化 (mCNV)。

Market Authorization Scope and Global Regulatory Status

市场授权范围和全球监管状态

The marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, under the European Economic Area (EEA) framework. Mynzepli is currently under regulatory review in both the United States and Japan.

该营销授权在所有27个欧盟成员国以及冰岛、列支敦士登和挪威的欧洲经济区（EEA）框架下均有效。Mynzepli目前在美国和日本正处于监管审查阶段。

The approval follows a joint press release by Alvotech, headquartered in Reykjavik, Iceland, and Advanz Pharma, based in London, UK.

该批准是在总部位于冰岛雷克雅未克的Alvotech公司和总部位于英国伦敦的Advanz Pharma公司联合发布的新闻稿之后获得的。

Supporting Clinical Data and CHMP Review

支持临床数据和CHMP审查

In early 2024, Alvotech released positive top-line results from a comparative clinical study evaluating Mynzepli against the reference aflibercept. The study demonstrated equivalent efficacy, safety, and immunogenicity, successfully meeting its primary endpoint.

2024 年初，Alvotech 发布了一项对比评估 Mynzepli 与参考药物阿柏西普的临床研究的积极关键结果。研究表明，两者的疗效、安全性和免疫原性相当，成功达到了主要终点。

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion in support of the biosimilar prior to final EC approval.

欧洲药品管理局 (EMA) 的人用医药产品委员会 (CHMP) 在最终获得欧盟委员会 (EC) 批准之前，采纳了支持该生物类似药的积极意见。

“Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options. This helps to ensure that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers,” said Joseph McClellan, Chief Scientific and Technical Officer, Alvotech..

“及时获得有效治疗对于受视网膜疾病影响的个体至关重要。随着数百万欧洲人受到影响，Mynzepli的获批代表了在提供创新且负担得起的治疗选择方面的重要进展。这有助于确保整个欧洲的患者无论面临经济还是物流障碍，都能更好地获得保护视力的医疗服务，”Alvotech首席科学与技术官Joseph McClellan表示。