EU Approves Byooviz Pre-Filled Syringe

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.

Expanded Formulation Aligns with Evolving Standards in Ophthalmic Care

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).

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.

Commercialization Strategy and Market Launch Plans

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.

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.

“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.