Samsung Bioepis introduced on Dec. 2 that the European Medicines Company (EMA)’s Committee for Medicinal Merchandise for Human Use (CHMP) has adopted a optimistic opinion for BYOOVIZ pre-filled syringe (PFS), a biosimilar referencing Lucentis1 (ranibizumab). BYOOVIZ was first permitted by the European Fee (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the therapy of neovascular (moist) age-related macular degeneration (AMD), visible impairment as a result of diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visible impairment as a result of macular oedema secondary to retinal vein occlusion (department RVO or central RVO) and visible impairment as a result of choroidal neovascularization (CNV).
The PFS presentation is considered the usual of care in ophthalmology, offering comfort for administration with exact dosing and ease of use with syringe injection, in addition to security advantages within the type of a decreased threat of endophthalmitis versus vials.2
“As Samsung Bioepis begins to commercialize BYOOVIZ in January 2026, the addition of this PFS presentation will present further worth for our stakeholders, by serving to suppliers handle ophthalmic circumstances with comfort for injection,” stated Antonio Rito, vp and head of Europe at Samsung Bioepis. “We are going to proceed to offer biosimilar medicines with improved product options to fulfill the wants of healthcare suppliers and sufferers.”
In October 2025, Samsung Bioepis introduced that the corporate will assume full industrial accountability for BYOOVIZ in Europe upon full transition of Biogen’s commercialization rights again to Samsung Bioepis efficient as of January 2026. The PFS presentation is predicted to be obtainable available in the market beginning within the second quarter of 2026.
