Pre-filled Syringe Presentation of BYOOVIZ®, Samsung Bioepis' Biosimilar to Lucentis (Ranibizumab), Gains European Approval

• European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for BYOOVIZ^® (ranibizumab) pre-filled syringe (PFS)
• PFS presentation to become available in Europe in the second quarter of 2026, after the full transition of commercial rights from Biogen back to Samsung Bioepis in January 2026

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ^® pre-filled syringe (PFS), a biosimilar referencing Lucentis¹ (ranibizumab). BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV).

The PFS presentation is regarded as the standard of care in ophthalmology, providing convenience for administration with precise dosing and ease of use with syringe injection, as well as safety benefits in the form of a decreased risk of endophthalmitis versus vials.²

“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.”

In October 2025, Samsung Bioepis announced that the company will assume full commercial responsibility for BYOOVIZ in Europe upon full transition of Biogen’s commercialization rights back to Samsung Bioepis effective as of January 2026. The PFS presentation is expected to be available in the market starting in the second quarter of 2026.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on social media – LinkedIn, X.

¹ Lucentis is a trademark of Genentech Inc.
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.