European Regulators Approve Pre-Filled Syringe Version of Byooviz, Lucentis Biosimilar

欧洲监管机构批准了Byooviz和Lucentis生物类似药的预充式注射器版本

December 03, 2025

2025年12月3日

Samsung Bioepis has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its pre-filled syringe (PFS) formulation of Byooviz, a biosimilar referencing Lucentis (ranibizumab). This regulatory milestone expands the Byooviz portfolio beyond its original single-use vial, which was approved by the European Commission (EC) in August 2021 for multiple ophthalmic indications..

三星Bioepis公司已获得欧洲药品管理局人用医药产品委员会（CHMP）对其预充注射器（PFS）配方Byooviz的积极意见，该药是参照Lucentis（雷珠单抗）的生物类似药。这一监管里程碑扩展了Byooviz的产品组合，超越了其最初的单剂量小瓶配方，后者已于2021年8月获得欧盟委员会（EC）批准用于多种眼科适应症。

Expanded Formulation Aligns with Evolving Standards in Ophthalmic Care

扩展的配方符合眼科护理标准的演变

The new PFS format is designed to meet the growing demand for more efficient, user-friendly delivery systems in ophthalmology. It retains all the approved indications of the original vial version, including wet age-related macular degeneration (AMD), diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), macular oedema secondary to branch or central retinal vein occlusion (RVO), and choroidal neovascularization (CNV)..

新的PFS格式旨在满足眼科对更高效、更用户友好的递送系统日益增长的需求。它保留了原始小瓶版本的所有已批准适应症，包括湿性年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿（DME）、增殖性糖尿病视网膜病变（PDR）、继发于分支或中央视网膜静脉阻塞（RVO）的黄斑水肿，以及脉络膜新生血管化（CNV）。

The pre-filled syringe presentation offers several advantages over traditional vial formats. It enables more precise dosing, enhances ease of use for physicians, and reduces the risk of contamination. A 2024 systematic review further supports the safety benefits of PFS formulations, noting a lower risk of endophthalmitis compared to vial-based injections..

预填充注射器相对于传统瓶装格式有几个优势。它能够实现更精确的剂量，增强医生使用的便捷性，并降低污染风险。2024年的一项系统评价进一步支持了预填充注射器配方的安全性优势，指出与基于瓶装的注射相比，发生眼内炎的风险更低。

Commercialization Strategy and Market Launch Plans

商业化战略与市场发布计划

The approval comes as Samsung Bioepis prepares to assume full commercial responsibility for Byooviz in Europe, following the return of rights from Biogen announced in October 2025. Effective January 2026, Samsung Bioepis will oversee all commercialization activities for the Byooviz product line across the region..

该批准正值三星生物制药准备在欧洲承担Byooviz的全部商业责任之际，此前百健于2025年10月宣布归还权利。自2026年1月起，三星生物制药将负责Byooviz产品线在整个地区的所有商业化活动。

The Byooviz pre-filled syringe is expected to be available in European markets in Q2 2026, aligning with the company’s broader strategy to enhance product usability and provider convenience.

Byooviz预充式注射器预计将于2026年第二季度在欧洲市场上市，这与公司提升产品可用性和供应商便利性的整体战略相一致。

“As Samsung Bioepis starts to commercialize BYOOVIZ in January 2026, the addition of this PFS presentation will provide additional value for our stakeholders, by helping providers manage ophthalmic conditions with convenience for injection,” said Antonio Rito, Vice President and Head of Europe at Samsung Bioepis..

“随着三星Bioepis于2026年1月开始将BYOOVIZ商业化，这种预充式注射器的加入将为我们的利益相关者提供额外价值，有助于医疗提供者更便捷地管理眼科疾病注射，”三星Bioepis欧洲副总裁兼负责人安东尼奥·里托表示。