Samsung Bioepis announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the Byooviz pre-filled syringe (PFS), a biosimilar referencing Lucentis (ranibizumab).
The decision expands the Byooviz portfolio beyond the single-use vial format that received European Commission (EC) approval in August 2021 for multiple ophthalmic indications, including wet age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), macular oedema secondary to retinal vein occlusion (branch or central RVO), and visual impairment due to choroidal neovascularization (CNV).
The newly approved PFS format reflects the evolving standard of care in ophthalmology, offering several advantages over vial presentations. Prefilled syringes help ensure more precise dosing, increase ease of use for physicians, and reduce the risk of contamination. According to a 2024 systematic review,² PFS presentations are associated with a lower risk of endophthalmitis.
“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. “We will continue to provide biosimilar medicines with improved product features to meet the needs of healthcare providers and patients.”
Samsung Bioepis announced in October 2025 that it will assume full commercial responsibility for Byooviz in Europe following the transition of Biogen’s commercialization rights back to the company, effective January 2026. The Byooviz PFS is expected to be available in European markets beginning in the second quarter of 2026.
References
2 Uzzan J, Mapani A, Cox O, Bagijn M, Saffar I. Clinical Outcomes and Experiences with Prefilled Syringes Versus Vials for Intravitreal Administration of Anti-VEGF Treatments: A Systematic Review. Ophthalmol Ther. 2024 Sep;13(9):2445-2465. doi: 10.1007/s40123-024-01002-0. Epub 2024 Jul 27. PMID: 39066961; PMCID: PMC11341511.
